Senior Manager, External Clinical Supply Quality (Biotherapeutics)
Job Function: Quality
Job Sub Function: Supplier Quality
Job Category: Professional
All Job Posting Locations: Schaffhausen, Switzerland
Job Description
* This position provides Quality Assurance, Compliance and Management oversight for External Manufacturers that are involved in development activities and production of clinical batches for Proteins and Advanced Therapeutics (DS & DP)
* Is responsible for the introduction of New Products at external partners and will drive the quality activities from first in human studies through to clinical phase 3.
* Drives Quality Assurance, Compliance and Technical Support for external manufacturers used for the manufacturing of Investigational Medicinal products.
* Supports the transfer process in late phase development to the IMSC organization.
* Supports the selection, qualification, monitoring and management of External Manufacturers in EMEA region.
* Contributes to the overall development, implementation and execution of quality systems in support of the external manufacturers.
* Provides quality leadership to business partners.
* Provides strategic direction from a Quality and Compliance point of view for the management of external manufacturers.
* Leads or participates in teams or major cross-functional project initiatives.
QA Responsibilities
* Provide cGMP direction to contract manufacturers by proactive management of quality using risk-based approaches.
* Drive phase appropriate GMP implementation at external manufacturers in early and late phase development to fulfill the business requirements.
* Collaborate with business partners globally and align with the TDS strategy.
* Assess current quality systems and recommend improvements to enhance quality and reduce cycle time.
* Monitor trends, identify issues, recommend and implement appropriate actions.
* Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
* Support the qualification of External Manufacturers and provide quality input during the selection process as a team member.
* Show leadership during regulatory inspections at EM’s and provides follow‑up on regulatory commitments.
* Develop, implement, and review of SOPs for interactions with External Manufacturers.
* Investigate customer product quality complaints.
* Apply cGMP regulations and other FDA/EMEA and international requirements to all aspects of the position.
* Coordinate change control documentation and approval process at EM.
* Coordinate and negotiate Quality agreement finalization/revision with EM. Drives the transfer process in late phase development to the JSC organization.
* Interface with other functions (DPDS, JJSA, Technical Operations, CSC, QA‑CSC, PQM, etc.) in support of External Manufacturing.
* Provide support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and external manufacturing.
* Remain current with EMEA/FDA and local GMP regulations, guidelines, and quality practices associated with the pharmaceutical industry.
Qualification
* University degree in Life Science (Pharmaceutical Chemistry and technology, Pharmacy, Engineering)
* Auditor Qualification for Quality Management System Auditor and Lead Auditor, compliant with ISO 9001 and EU‑GMP standards
Experience and Skills Required
* Minimum 10+ years in pharmaceutical quality roles, with at least 2 years in global environment.
* Minimum 10+ years of experience in an FDA/EMA regulated chemical/ pharmaceutical environment.
* Proven experience in external manufacturing and supplier quality management.
* In-depth understanding of pharmaceutical product development, method development, qualification, manufacturing, validation, testing, release and distribution processes.
* Up-to‑date knowledge and in‑depth understanding of relevant pharmaceutical legislation, legislation related to method development, Clinical Trials and cGMP and GDP regulations (Eudralex, ICH, Ph.Eur., USP, FDA, etc) at global, regional and national levels.
* Have actively participated (e.g. as Subject Matter Expert) in health authorities’ inspections (e.g. EMA, ANVISA and FDA)
* Strong analytical thinking, decision‑making and leadership skills.
* Proven experience managing collaborations with external partners in complex operational contexts.
* Excellent verbal and written communication skills, supporting effective negotiation and relationship‑building with external and internal stakeholders.
* Significant experience in the development, implementation of quality systems and interactions with contract manufacturers.
* Strong experience in aseptic pharmaceutical manufacturing
* Knowledge of biological manufacturing and advanced therapeutics, including DS and DP.
* Strong ability to deliver cGMP compliance support to contract manufacturers by leading investigations and resolving quality issues.
* Demonstrated capability to independently manage and resolve complex Quality and Compliance challenges in External Manufacturing.
* Demonstrated ability to independently manage multiple external manufacturing partners, including complex sites, to deliver on project objectives and timelines.
* Ability to work within multiple cross functional teams with global composition.
* Leadership and influencing skills
* Fluent in English, both written and spoken.
Demonstrates mature skills in the following Global Leadership areas
* Integrity and Credo Based Actions
* Big Picture Orientation with Attention to Detail
* Intellectual Curiosity
* Sense of Urgency
* Results and Performance Driven
* Collaboration and Teaming
* Prudent Risk Taking
* Self‑Awareness and Adaptability.
Location
Switzerland (Schaffhausen)
Travel
Position requires occasional travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight (appr. 30%).
Required Skills
* Compliance Management
* Consulting
* Cross‑Functional Collaboration
* Mentorship
* Organizing
* Performance Measurement
* Product Testing
* Quality Control (QC)
* Quality Management Systems (QMS)
* Quality Standards
* Quality Validation
* Relationship Building
* Stakeholder Management
* Standard Operating Procedure (SOP)
* Technical Credibility
* Vendor Selection
Preferred Skills
* Compliance Management
* Consulting
* Cross‑Functional Collaboration
* Mentorship
* Organizing
* Performance Measurement
* Product Testing
* Quality Control (QC)
* Quality Management Systems (QMS)
* Quality Standards
* Quality Validation
* Relationship Building
* Stakeholder Management
* Standard Operating Procedure (SOP)
* Technical Credibility
* Vendor Selection
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