Associate Director – QA Support Functions (6654)

Overview

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 awareness of the corresponding quality performance metrics with a drive for improvement.

Project management and project realization in complex cross-functional and 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 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 with capability to efficiently isolate GMP relevant key indices, lead of team to perform initial risk assessments, oversee the investigation, jointly generate deviation reports with the owner to ensure compliance, establish root cause and define 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 decisions about use of materials based on Global Logistics Quality requests.
• Second approval of deviations.
• Management of changes as “Quality Delegate” function with ability to isolate GMP relevant key indices, 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 are compliant to set change into “Release to Implementation (RTI) or “Release to Operation” / RTO and close change when completed in 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 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
• Profound expertise in:

• 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.

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