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Dr.

Inci Akkus

Strategic interim leadership at turning points.

Driving transformation where leadership is critical.

from 01.04.2026
Interim Manager since: 02/2005
Update: 09.03.2026

Specialist groups

  • DDIM.fachgruppe // Digitalisierung
  • DDIM.fachgruppe // International
  • DDIM.fachgruppe // Projekt- & Programmmanagement

Contact data

AKS.Interim, Köln

Damianstr, 1
D-50765 Köln
rq.zvergav-fxn@vpav

Telefon Mobile
+49 1743666966

Short profile

Intro
As an interim executive, I step in when leadership, clarity and direction are urgently needed – during transitions, transformations or critical operational phases. With 20+ years of international experience in MedTech, Pharma, logistics and manufacturing, I operate at the intersection of strategy, execution and regulatory precision.
My strength lies in mastering complexity and delivering traction – in digital transformation programs, global restructuring initiatives or high-stakes compliance projects.
 
Please explore my profile to learn more about the services I offer. I look forward to connecting with you!
Experience overview
Extensive interim and project leadership in global corporations – where operational transformation, regulatory depth and strategic navigation converge (Site evaluations & manufacturing setup, Digitalization, regulatory, Executive interim roles (CRO, COO)
I join when structures shift – and leave when they hold again.
Tasks
  • Management
  • Digitization
  • Internationalization
  • Cost Reduction
  • Restructuring / Reorganization, close to insolvency
Functions
  • Management / General Management / Board
  • Information Technology
  • Operations
  • Organization
  • Production
Role in the company
  • Staff function / Expert / Specialist
  • 2nd Level / Division Management / Department Management
  • 3rd and 4th Level
  • Program Manager
  • 1st Level / Executive Board / Management
Industry experience
  • FMCG
  • Healthcare
  • Medical Technology
  • Pharmaceutical Industry
  • Electrical Engineering / Electronics
Type of company
  • Owner-managed / Family Business
  • Corporation / Group
  • Medium-sized Enterprise
  • Start-up
Regions (Regions where you have proven experience)
  • Asia
  • Europe (EU)
  • Europe (not EU)
  • North America
  • Switzerland
Languages
  • German (Mother tongue)
  • English (Conversational)
  • Turkish (Good)
Special certificates and awards
IP & Patentschutz China (Executive Training M-BL)
PMP® – Project Management Professional
Harvard Law School – Program on Negotiation (PON)
Executive M.B.L.–HSG (Universität St. Gallen)
MBA (University of East London)
Executive PhD Program (Universität Antwerpen)
Special skills
C-Level-Advisory mit Tiefgang
Methodenkompetenz auf höchstem Niveau
Kommunikationsstärke & Stakeholder Management
Leadership Excellence & Teamentwicklung
Innovation & Digitalisierung in hochkomplexen Umfeldern
Internationale Strategie- und Umsetzungskompetenz
Regulierte Branchen meistern
High-Impact-Transformation & Turnaround

IM projects (self employed)


Company description

Medical equipment / Pharma Industry

Company turnover in Mio $
8400 Mio USD
Number of employees in company
1500
City / place
Graz

Initial situation at the client

Fresenius Kabi Austria faced a complex GMP-regulated transformation. An interim executive with a strong background in regulatory operations, strategic change, and digital innovation was required to safeguard pilots, establish scalable structures, and drive future-oriented processes. My expertise ensured the alignment of compliance, operational resilience, and organizational readiness.

Area of responsibility (sales and employees)
Responsible for the strategic direction and facilitation of digital transformation in a strictly regulated GMP environment. Designed a forward-looking EBR and change concept, advised executive leadership, integrated regulatory and CSV requirements into operational frameworks, defined governance structures, identified transformation levers, and enabled cultural and procedural readiness for future compliance and scalability.

Mission
  • Strategic advisory to executive leadership on GMP-compliant digitalization
  • Development of an enterprise-wide EBR transformation concept
  • QMS evaluation and restructuring to support future scalability
  • Regulatory integration into transformation planning and design
  • Enabling change and stakeholder alignment across leadership layers
Measures taken
  • Facilitated strategy and decision-making workshops with executive and QA leaders
  • Developed a forward-compatible CSV approach for digital systems
  • Identified and prioritized change levers across organization, tech and culture
  • Designed a governance and communication model to guide execution
  • Conducted risk and readiness assessments with focus on regulatory compliance
Achieved Achievements
  • Clear strategic direction for digital GMP transformation established
  • Blueprint for scalable and compliant EBR implementation delivered
  • Mitigated transformation risks through structured early-stage planning
  • Enabled regulatory alignment and strengthened audit preparedness
  • Empowered leadership with change tools and cross-functional ownership
Special challenges
High complexity as several couple of hundred SOPs are affected, uneven change readiness, streamline global procedures with local demands and requirements. Balance standards and noms of the industry with scalability and business continuity. Strong communcation and stakeholder management

Company description

RENOLIT SE is an internationally active specialist in high-quality plastic films, sheets, and other polymer products. The company serves a wide range of industries, including automotive, medical techn

Company turnover in Mio $
1400 Mio USD
Number of employees in company
5000
City / place
Global

Initial situation at the client

RENOLIT SE faced the strategic and operational challenge of restructuring several international production sites. Executive leadership required an external interim executive with deep restructuring expertise to address inefficiencies, embed regulatory frameworks, and realign the organization for sustainable growth, profitability, and transformation readiness.

Area of responsibility (sales and employees)
Full responsibility for the strategic and operational restructuring of multiple European production sites. Designed and led a group-wide transformation framework including leadership reorganization, quality management (QMS, ISO 13485), portfolio realignment, and governance redesign. Acted as a close advisor to executive management and board-level stakeholders in a politically sensitive, high-impact setting.
Mission
  • Developed and led group-wide restructuring and footprint strategy
  • Assessed and repositioned production network through site evaluations and relocation scenarios
  • Managed full-cycle execution of site closures and production transfers
  • Created “Building the Future” location strategies for emerging markets (Asia, MENA)
  • Established portfolio governance and PMO for strategic transformation
  • Elevated decision-making across executive and operational levels
Measures taken
  • Conducted comprehensive European site assessments incl. business case & risk modelling
  • Designed and deployed strategic portfolio process incl. exit & investment scenarios
  • Led complex closure/transfer operations including stakeholder & labor alignment
  • Implemented scalable transformation infrastructure (PMO, project controls, KPIs)
  • Developed greenfield site concepts aligned with future markets and compliance needs
  • Enabled leadership readiness through structured coaching and governance alignment
Achieved Achievements
  • Delivered successful site closures and relocations with full business continuity
  • Increased EBIT contribution through footprint optimization
  • Enabled global expansion readiness through validated site strategies (Asia/MENA)
  • Embedded strategic transformation into day-to-day leadership routines
  • Reduced organizational risk through proactive portfolio and compliance integration
Special challenges
  • Balancing political dynamics across shareholders, labor councils and local management
  • Managing simultaneous shutdown, relocation, and setup initiatives
  • Limited maturity in project and change structures at plant level
  • Integrating financial, regulatory, and cultural risk into strategic site decisions
  • Ensuring future readiness under live production conditions

Company description

International companies across: MedTech & Pharma Logistics & Transportation Food Industry Telecommunications Automotive & eCommerce

Company turnover in Mio $
50000 Mio USD
Number of employees in company
100000
City / place
Global

Initial situation at the client

Most clients were in transition: market expansion, restructuring, post-merger integration, or early-stage operations. Interim leadership was required to bridge management gaps, stabilize operations, or execute strategic initiatives.

Area of responsibility (sales and employees)
Assumed temporary executive roles (e.g., COO, Program Director) with a focus on production strategy, supply chain setup, IT alignment, and structural scalability across multinational environments.
Measures taken
Deployed Lean operations and performance management frameworks
Conducted site evaluations and set up new operations in MENA, Asia, Eastern Europe
Led program and portfolio governance across corporate functions
Implemented quality, process, and training systems
Drove digital transformation of manual operations
Achieved Achievements
Smooth handover of stabilized business units after interim phase
New markets and sites launched with regulatory approval
Substantial efficiency gains through structural optimization
Risk mitigation and improved governance in critical supply chains
Special challenges
Volatile political and regulatory environments (e.g., Turkey, Russia)
Intercultural leadership across Europe, Asia, and MENA
Time-critical implementation without established organizational frameworks

Company description

Company turnover in Mio $
1900 Mio USD
Number of employees in company
75000
City / place
International

Initial situation at the client

As part of its digital roadmap, DB Schenker initiated the implementation of a global eIPaaS platform. Key internal leadership roles were temporarily unfilled. An experienced interim executive with strategic PMO capabilities was appointed to provide structured oversight, align stakeholders, and stabilize delivery conditions.

Area of responsibility (sales and employees)
As part of its digital roadmap, DB Schenker initiated the implementation of a global eIPaaS platform. Key internal leadership roles were temporarily unfilled. An experienced interim executive with strategic PMO capabilities was appointed to provide structured oversight, align stakeholders, and stabilize delivery conditions.
Mission
Assumed temporary leadership of the strategic eIPaaS rollout. Assessed project maturity, established governance contours, connected operational realities with digital ambitions. Served as strategic sparring partner to executive functions.
Measures taken
Executed rapid situational analysis, mapped critical integration tracks, set up compliance-aligned program structure. Initiated C-level dialogue, clarified risk landscapes, and designed a handover-ready leadership framework.
Achieved Achievements
Ensured program continuity during a critical interim phase. Re-established strategic steering capacity. Defined scalable governance foundations. Clarified accountability and dependencies across functions and geographies.
Special challenges
High expectations for clarity and traction in minimal time. Ambiguity between line and program ownership. Varied digital maturity across global units. Politically sensitive environment due to pending internal appointments.

Company description

BIOTRONIK SE & Co. KG is a leading global medical technology company headquartered in Berlin, Germany. The company develops and manufactures devices for cardiac rhythm management, electrophysiology, a

Company turnover in Mio $
1500 Mio USD
Number of employees in company
9000
City / place
Global

Initial situation at the client

BIOTRONIK initiated a global CTMS implementation to standardize clinical processes and ensure full compliance with GCP and FDA regulations. Existing systems were fragmented, partly manual, and lacked scalability. The company required external leadership with regulatory expertise to guide vendor selection, ensure compliance, and manage a risk-controlled rollout.

Area of responsibility (sales and employees)
Led Phase I of the global implementation of a new Clinical Trial Management System (CTMS). Strategic advisory on vendor selection, compliance, data migration, and change enablement across global R&D teams.
Mission
BIOTRONIK initiated a global CTMS implementation to standardize clinical processes and ensure full compliance with GCP and FDA regulations. Existing systems were fragmented, partly manual, and lacked scalability. The company required external leadership with regulatory expertise to guide vendor selection, ensure compliance, and manage a risk-controlled rollout.
Measures taken
Managed vendor selection, defined regulatory requirements, built governance model, created rollout plan. Facilitated stakeholder workshops and aligned IT, QA, and clinical operations.
Achieved Achievements
Validated system architecture and achieved global approval. Prepared data migration, ensured GCP/FDA compliance. Strong stakeholder buy-in. Global rollout initiated with structured oversight.
Special challenges
complex alignments across all parties and external partners, collect US requriements FDA vs MDR; tight timeline, business readiness, costs structure, big bang vs iterative approach, project progress vs change readiness and PM approach in an clinical environment 

Company description

DB Schenker is a global leader in logistics and supply chain management. Headquartered in Germany, the company employs around 75,000 people across more than 130 countries and generated approx. €19 bil

Company turnover in Mio $
19000 Mio USD
Number of employees in company
75000
City / place
Global

Initial situation at the client

As part of a global HR digitalization program, DB Schenker was rolling out SuccessFactors across 77 countries. Due to internal bandwidth limitations, I was brought in as an Interim Executive to ensure program stability, strategic alignment, and leadership continuity during a critical integration phase.

Area of responsibility (sales and employees)
Assumed temporary program lead for global HRIS integration. Aligned architecture and rollout streams, ensured data harmonization, and reinforced program governance between design and operations. Enabled coordination between central HR, IT, and regional entities.
Mission
Temporary leadership of the global program during a volatile transitional period
Securing continuity across organizational, technical, and political interfaces
Designing governance frameworks for group-wide data harmonization and deployment
Coordinating regional workstreams and stakeholder landscapes across 77 countries
Mitigating risk through structured escalation and communication strategies
Measures taken
Designed integration and data governance model for 77-country rollouts
Developed global control structure for field mapping and data harmonization
Temporarily led regional integration workstreams (EMEA, APAC, Americas)
Established cross-functional communication channels for internal alignment
Achieved Achievements
Secured program stability and leadership handover readiness
Standardized global data definitions and integration logic
Reduced redundancy and clarified IT/HR interface responsibilities
Enabled controlled transition into rollout phase with full visibility
Special challenges
High regulatory and structural diversity across geographies
Varying levels of change maturity across regions
Intercultural coordination across time zones and HR realities
Simultaneous implementation and internal HR transformation

Company description

BioNTech SE is a leading German biotechnology company specializing in mRNA-based therapies for cancer and infectious diseases. The company gained prominence through the development of the first approv

Company turnover in Mio $
3800 Mio USD
Number of employees in company
1650
City / place
IdarOberstein

Initial situation at the client

Following the success of its COVID-19 vaccine, BioNTech faced the challenge of digitizing and scaling its clinical trial processes, particularly in oncology. The existing IT landscape was fragmented, lacking standardized digital processes for conducting global studies. An interim manager with strategic expertise in clinical operations and digitalization was appointed to bridge internal resource gaps.

Area of responsibility (sales and employees)
Temporary leadership of the program for digital transformation of clinical trials. Responsibilities included developing a digital roadmap, selecting and implementing suitable eClinical systems, and establishing a governance structure to ensure regulatory compliance.
Measures taken
Analyzed existing clinical processes and IT systems?
Developed a digitalization strategy for clinical trials?
Selected and implemented a Clinical Trial Management System (CTMS)?
Established a change management plan to promote adoption?
Conducted training for staff and stakeholder communication
Achieved Achievements
Implemented a global CTMS to standardize clinical processes?
Reduced study preparation time by 25%?
Improved data quality and availability?
Enhanced compliance with regulatory requirements
Special challenges
Coordinating between various departments and international sites?
Adapting to different regulatory requirements across countries?
Ensuring data integrity during system migration?
Promoting acceptance of new digital processes among staff

Company description

akeda is a global biopharmaceutical leader headquartered in Tokyo, Japan, operating in over 80 countries. The company focuses on oncology, immunology, neuroscience, and rare diseases. In 2021, Takeda

Company turnover in Mio $
31000 Mio USD
Number of employees in company
49000
City / place
Singen

Initial situation at the client

As part of its global “ONE Takeda” strategy, the company initiated a strategic review of a former Shire manufacturing site in Europe. Following this evaluation, Takeda required interim leadership to drive the digital transformation of site operations and align local systems with the global digital manufacturing architecture.

Area of responsibility (sales and employees)
Phase 1: Led a holistic site assessment (strategic, operational, regulatory, and economic) to inform global portfolio decisions.
Phase 2: Assumed interim digital operations leadership to design and implement a digital manufacturing strategy, including MES rollout, process digitalization, and global system harmonization.
Mission
Two Phase approach 
Measures taken
Conducted site-wide evaluation: technology, workforce, compliance, economic viability
Developed decision papers for integration into Takeda’s global network
Designed and implemented digital operations model aligned with corporate standards
Launched MES program, integrated local and global system architectures
Built change management framework to enable GMP-compliant digital production culture
Coordinated with Global Digital Manufacturing and Corporate Engineering functions
Achieved Achievements
Enabled full integration of site into global operating model
Structured and initiated MES deployment across all production areas
Standardized digital KPIs and aligned with Takeda’s global reporting logic
Established local digital leadership council for strategic production decisions
Uncovered real-time efficiency and compliance gaps for executive decision-making
Special challenges
Strict GMP compliance requirements and legacy IT infrastructure
Cultural and operational friction between Japanese HQ and European plant dynamics
Varying levels of digital maturity across sites and functions
Organizational resistance during global integration under high strategic pressure

Education

Notes / specifics
Managing government affairs in China : medical technology firms’ challenge of protecting and enforcing their intellectual property rights

Documents and files

CV / Kurzprofil Dr. Inci Akkuspdf

189.31 KB
CV

Kurzprofil

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