Drug Product MSAT and Outsourcing Lead

Randstad; Genf; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Randstad is seeking a highly skilled Drug Product Outsourcing Lead to serve as the primary contact for CMOs. You will lead cross-functional teams to drive operational excellence, ensure compliance, and mitigate supply and quality risks, while managing technology transfers and ensuring OTIF delivery of CMC and regulatory deliverables.

You will oversee regulatory strategy for new market registrations in the USA and EU, maintain product licenses, and manage project budgets with a focus on cGMP

Qualifikationen

• Minimum 5 years in Drug Product manufacturing or CDMO management.
• Strong MSAT background in process development, tech transfer, and validation.
• Fluent in English and French with regulatory knowledge.

Aufgaben

• Act as SPOC and lead cross-functional Virtual Plant Teams for CMOs on DP MSAT activities.
• Drive OTIF delivery of CMC and technical deliverables to CMOs and business partners.
• Maintain the state-of-validation through process monitoring, APQRs/PQRs, and CPV.
• Oversee manufacturing deviations, change controls, and CAPAs with cGMP regulatory alignment.
• Manage budgeted costs for CMOs, including forecasting and cost-benefit analyses.
• Foster strategic partnerships with external manufacturers through governance & site visits.
• Contribute to continuous improvement of outsourced manufacturing oversight and cross-functional collaboration.

Kenntnisse

MSAT

Process development

Technology transfer

Validation

Vaccine/biologics

cGMP

Leadership

Communication

English

French

Jobbeschreibung

Location: Geneva, Switzerland (Minimum 4 days office presence per week)

Travel Requirements: 20-30% (Includes site visits to European, US, and Asian manufacturing partners)

Reporting To: Head of Industrial Affairs

Position Summary

We are seeking a highly skilled Drug Product Outsourcing Lead to serve as the primary point of contact for our Contract Manufacturing Organizations (CMOs). In this critical role, you will lead cross-functional Virtual Plant Teams to drive operational excellence, ensure compliance, and mitigate supply and quality risks. You will manage technology transfers and ensure the On-Time-In-Full (OTIF) delivery of CMC, technical, and regulatory deliverables while adhering to budget and quality standards. Additionally, you will maintain commercial product licenses and ensure compliance for new market registrations (USA and EU).

Key Responsibilities

Technical Stewardship & CMO Oversight

• Act as the Single Point of Contact (SPOC) and lead cross-functional Virtual Plant Teams for CMOs regarding Drug Product MSAT activities, including process improvements, compliance, and tech transfers.
• Drive OTIF delivery of CMC and technical deliverables to CMOs and business partners.
• Maintain the state-of-validation through process monitoring, APQRs/PQRs, and Continuous Process Verification (CPV).
• Oversee manufacturing deviations, change controls, and CAPAs from CMOs, conducting risk-based assessments and root cause investigations while ensuring alignment with cGMP, FDA, and EMA regulations.
• Manage budgeted costs for CMOs, including financial forecasting, variance reporting, and cost-benefit analyses for technology transfers and process optimizations.
• Foster strategic partnerships with external manufacturers through governance frameworks, site visits, and science-based support for lifecycle management.
• Contribute to the continuous improvement of internal processes regarding outsourced manufacturing oversight and cross-functional collaboration.

Technical Information Management

• Develop and maintain comprehensive technical dossiers for all assigned products (manufacturing process descriptions, process parameters, control strategies).
• Manage the internal repository of critical manufacturing documentation, including CMC dossier components and batch record summaries.
• Provide technical input and regulatory strategy recommendations for manufacturing-related changes.
• Support the management of Health Authority Questions related to manufacturing and Post-Approval Commitments in collaboration with CMOs, SMEs, and Regulatory Affairs.

Quality & Deviation Management

• Evaluate major deviations and change controls from a technical perspective, focusing on product quality, risk mitigation, and regulatory compliance.
• Review Impact Assessments and CAPAs, providing guidance in collaboration with CDMO partners and internal Quality Assurance.
• Participate in customer complaint investigations and field failure management related to outsourced manufacturing, escalating critical issues as necessary.

Qualifications & Requirements

• Experience: 5+ years in pharmaceutical Drug Product (DP) manufacturing or CDMO management.
• Technical Expertise: Strong MSAT background in process development, technology transfer, and validation. Specific expertise in vaccines/biologics (lyophilization and fill-finish) is highly preferred.
• Regulatory Knowledge: Deep understanding of cGMP requirements, FDA and EMA regulations, and CMC regulatory submissions (CTD Module 3).
• Leadership & Collaboration: Proven ability to lead cross-functional teams, manage CMO relationships, and utilize tools like FMEA/QRM.
• Problem-Solving: Excellent technical problem-solving skills with a meticulous, data-driven approach to decision‑making.
• Communication: Exceptional communication and negotiation skills for engaging with external partners and internal stakeholders. Must have technical authority and credibility.
• Languages: Fluent in both English and French.
• Mindset: Entrepreneurial, innovative, pragmatic, and solution‑oriented.
• Bonus: Experience in Drug Substance (DS) biological manufacturing is considered a strong asset.