Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do.
Position Title: Senior Pharmaceutical Site Transfer Lead
Location: Barcelona
Type of Contract: Full-Time / On site
FLUENT IN SPANISH AND ENGLISH IS MANDATORY. FRENCH IS A PLUS.
Job Description
The Senior Pharmaceutical Site Transfer Lead is a strategic and highly experienced leader responsible for directing the full transfer of a pharmaceutical manufacturing facility—its operations, systems, technologies, personnel capabilities, and regulatory commitments—from the originating company to the receiving organization. This senior role is accountable for ensuring that the transition is executed flawlessly, maintaining compliance, product quality, and supply continuity throughout the entire process.
As a senior leader, this position influences decision‑making at the executive level, establishes governance structures, and drives alignment across multiple global stakeholders. The role requires deep technical expertise in GMP manufacturing, extensive experience in large‑scale tech transfers or site integrations, and exceptional leadership capabilities in complex multi‑company environments. The Senior Lead ensures that the transfer is not only technically successful but also strategically integrated into the receiving company's long‑term operational model.
Key Responsibilities
Strategic Program Leadership
- Act as the primary strategic owner of the site transfer, setting the vision, direction, and success criteria for the transition.
- Lead cross‑company governance bodies, including executive steering committees, ensuring rapid resolution of high‑impact risks and alignment with corporate objectives.
- Develop and maintain a comprehensive Site Transfer Master Plan, incorporating operational, quality, technical, regulatory, and financial dimensions.
- Provide high‑level reporting to senior leadership, highlighting risks, opportunities, and business impacts.
Technical, Quality, and Operational Integration
- Oversee the transfer of all manufacturing processes, ensuring readiness of equipment, facilities, utilities, automation, and operational capabilities at the receiving site.
- Direct the transfer of quality systems, including QMS integration, deviation and change control migration, document harmonization, and data integrity validation.
- Ensure alignment across process validation, cleaning validation, analytical method transfer, and equipment qualification activities, working closely with SMEs and QA leaders.
- Evaluate and guide technical remediations, equipment upgrades, or facility modifications needed to ensure GMP compliance and seamless integration.
Regulatory and Compliance Leadership
- Serve as the senior point of contact for regulatory strategy in support of the site transfer.
- Provide oversight for regulatory submissions (variations, supplements, site change documentation) and ensure they are fully aligned with global health authority expectations (FDA, EMA, WHO, PIC/S).
- Ensure the receiving facility is inspection‑ready at all phases of the transfer and support both internal and external regulatory audits.
Business Continuity and Supply Assurance
- Develop and manage robust supply continuity strategies, including dual supply windows, inventory planning, and risk‑based changeover strategies.
- Lead mitigation actions and contingency plans to avoid supply interruptions during critical project phases.
- Align the transfer roadmap with long‑term business forecasts, capacity strategies, and lifecycle management plans.
Cross‑Functional & Cross‑Company Leadership
- Lead large, multicultural, cross‑functional teams across manufacturing, engineering, QA, QC, EHS, supply chain, IT, HR, legal, and regulatory.
- Identify operational and cultural gaps between the two companies and drive convergence through structured change management.
- Oversee capability assessments and workforce transition plans, including training, competency mapping, and knowledge transfer frameworks.
Risk Management & Decision-Making
- Lead high‑level Quality Risk Management (QRM) processes, ensuring structured identification, evaluation, and mitigation of all technical and business risks.
- Make senior‑level decisions on resource allocation, remediation priorities, and technical solutions impacting project cost, timeline, and regulatory compliance.
- Ensure all risks have documented owners, mitigation strategies, and governance oversight.
Qualifications & Senior Competencies
Education & Experience
- Master's degree or higher in Engineering, Pharmacy, Chemistry, Biotechnology, or a related technical field (PhD desirable).
- 10+ years of experience in GMP pharmaceutical manufacturing, with significant exposure to technology transfer, site startups, or large‑scale integration programs.
- Proven track record leading cross‑company or cross‑site transformation projects with strategic impact.
- Strong understanding of global GMP requirements, including FDA, EMA, ICH, and PIC/S expectations.
Advanced Technical Expertise
- Deep knowledge of process engineering, validation, automation, aseptic or sterile systems, cleaning strategies, utilities, and facility qualification.
- Demonstrated ability to execute or oversee complex method transfers and analytical integration.
- Strong command of QMS frameworks and compliance structures.
Leadership & Behavioral Competencies
- Senior‑level communication, influencing, and stakeholder management skills.
- Ability to navigate ambiguity, make high‑impact decisions, and lead large teams under pressure.
- Executive‑level presence, capable of aligning diverse groups and gaining buy‑in from senior leadership.
- Strong strategic mindset with hands‑on execution capability.
What We Offer:
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Competitive compensation based on experience and project scope
- Exposure to international pharmaceutical operations and regulatory environments
- Opportunity to lead high-impact injectable validation programs
- Flexible work arrangements and travel support
- Collaborative and technically driven work culture
Join us: If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards in the Pharmaceutical Industry, we encourage you to apply. Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.
Efor is an equal opportunity employer and welcomes applicants from all backgrounds.
Thank you for your consideration and application! We review all resumes and submissions; however, due to the high volume of applications we receive, only approved candidates will be contacted.
