Associate Director - QA Support Functions – 6654 ADA

Associate Director – QA Support Functions – 6654 ADA

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.

We are seeking a highly skilled Associate Director – QA Support Functions for a 12-month contract position at our client\’s headquarters in Bern .

In this role, you will be responsible for all routine and non-routine quality oversight activities in collaboration with the operational organizational units of local Maintenance & Utilities , Quality Control , local warehouse and internal transports and qualification activities in Opex projects as well as periodic Requalification activities . This includes operational quality management according to cGMP to assure appropriate quality of the services provided to the Value Streams, review and approval of related complex GxP records , support and approval of complex quality risk assessments, non-conformances, investigations, CAPAs, change controls and is aware of the corresponding quality performance metrics and provides improvement for them.

Project management and project realization in complex cross functional and also global projects. Subject Matter Expert for complex deviations and changes during inspections and audits. Acts also globally with other QA Support Functions (QA SF) units.

Main Responsibilities:

• Ensures Quality Assurance oversight and drives quality decisions jointly with the stakeholders in the areas of maintenance / utilities, utility monitoring, material management, warehousing, and quality control to maintain compliance in the specified areas.
• Partnering and influencing of relevant stakeholders in maintenance, utilities engineering, quality control and local warehouse to maintain compliance and adhere to QA standards .
• Periodic quality oversight floor tours in warehouse with warehouse supervisor and Supply Chain with regard to improvement, exception handling and quality decisions (material usage decisions).
• Drives evaluation and implementation of new Quality on the Floor activities .
• Management of deviations as “Assigned to” Quality function for minor, major and critical deviations with profound capability to efficiently isolate GMP relevant key indices incl. lead of team to performing initial risk assessments, Quality on the Floor oversight of the investigation, jointly generation of deviation reports with the owner to ensure compliance, establishing root cause and defining CAPAs.
• QA approval/closing of deviations, effective CAPAs and recurrence investigations support.
• Manages independently and proactively complex and cross-functional local and cross-site deviations
• Actively drives reduction of recurrence by proposing efficient sustainable CAPAs
• Assesses excursions during transport of analytical samples and decides about use (compliance decision)
• Assesses transport damages of transports to affiliates / in affiliates warehouse and makes decision about use of materials based on Global Logistics Quality requests
• Second approval of deviations
• Management of changes as “Quality Delegate” function with profound capability to efficiently isolate GMP relevant key indices incl. support of the coordinator of changes, initial classification of changes, oversight of assessments and actions, inform customers, participate in Change Control Panel, approval of changes, QA approval of actions, assess change status and ensure all activities to be compliant to set change into “Release to Implementation (RTI) or “Release to Operation” /RTO) and close change when completed on a timely manner.
• Participates in Global Change Panel for major changes
• QASF assessment of changes
• Raw materials : Review and completion of APR/PQR regarding raw material data. Review for trending and clusters for rejected lots
• Reviews and provides QA approval for GxP documentation in the specified areas of duty, including complex documents e.g. QA representative in complex team risk analyses.
• Responsible for defining review criteria for non-routine documents, formats in development and QA decision
• Coordinates and performs qualification of new employees in GMP trainings in QA Support Functions and other Quality units.
• Develops new QA SF and cross-functional qualifications and concepts.
• Prepares and presents independently quality investigations and changes to health authorities in area of duty.
• Hosts authority inspections
• Topic Manager and Subject Matter Expert for authority requests
• Designated operational support of QA systems, testing of new versions, improvements, etc. (e.g. Veeva)
• Data generation and evaluation for e.g KPIs , elaborates decision basis
• QA lead in large complex cross functional and global projects

Qualifications & Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Master or Graduate university degree in relevant discipline (or equivalent)
• 8 years or more working in a similar role with demonstrated independent way of working and self-driven learning ability

– cGMP and Compliance

– Engineering maintenance operations

– Utility monitoring programs

– Material management and warehousing & logistics

– Quality control & analytical methods

– Change control management

– Deviation management

– CAPA management

• Mentoring / coaching of colleagues in domain of expertise
• Strong ability to network across departments to liaise for efficient collaborations

Seniority level

• Not Applicable

Employment type

• Contract

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing

We’re not able to offer the role to all applicants. Referrals may increase your chances of interview.

We’re not able to offer the role to all applicants. Referrals increase your chances of interviewing at CTC Resourcing Solutions by 2x.

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