Associate Director GQA External Quality & Supplier Quality Management - Switzerland
Want to know company name or location? Company managed [?]
- Our company is a research-driven, specialty biopharmaceutical group active in global markets.
- The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics.
- Our company has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
- Steward the quality systems and processes related to material specifications management and supplier quality management within our company , medical devices, and food supplement development, manufacturing and distribution operations
- Responsible for oversight and decision related to the quality management of shared suppliers.
- Identify, prevent and mitigate commercial supplier quality risks which can affect market supply continuity and our company’s business.
- Drive / Develop effective Global Quality systems and standards for product/material specifications and vendor quality management including sourcing, qualification, monitoring, and discontinuation and ensure applicability to late stage development and commercial supply operations.
- Lead or support assigned continuous quality improvement projects in relation to external quality and vendor quality management.
- Develop, implement and manage global processes and repositories to support knowledge transfer between R&D and commercial operations over material and product specifications and material supplier management.
- Organise the Supplier Quality Management governance in coordination with Global Purchasing to align the supplier segmentation (Food Supplement, Med. devices, and Pharma related) and identify quality ownership for the corresponding suppliers
- Establish and maintain a Global Supplier Quality Responsibility matrix for shared suppliers (between sites and functions) and assign the company site lead as QTA contract giver
- Ensure Quality Technical Agreements (QTA) with adequate requirements are established with all critical shared suppliers, as determined through supplier segmentation process.
- Ensure material specifications and acceptance quality levels (AQL) are defined in accordance with risk management principles.
- Define a strategy and program for quality inspection of incoming purchased materials.
- Carry out directly or through global quality oversight the supplier quality assessment and develop the supplier audit programme accordingly (for shared suppliers).
- Carry out assigned quality audits in connection to supplier quality management.
- Review periodically the quality
- Establish and lead the Global Quality Review Board for shared suppliers in accordance with supplier segmentation principles and specific QRBs for API, Med devices, Excipients , Food Supplements, Primary and sec. packaging materials, etc, wherever applicable.
- Collect, review, improve quality metrics to actively monitor supplier quality compliance and performance and detect early signs of quality deficiencies before they can severely impact the business.
- Capture identified quality gaps / risks related to shared suppliers management in a risk register and implement a Quality Plan to prioritize the remediation efforts.
- Represent GQA in KSM teams for assigned supplier(s) and take ownership on all associated quality matters in terms of manufacturing and supply chain.
- Take the lead on investigations at suppliers for recurrent / critical quality situations which jeopardize commercial supply continuity.
- Carry out assigned due diligence audits in the frame of external quality management for new product acquisition of sourcing of new strategic suppliers.
Required Experience & Skills
- University degree in Pharmacy or comparable science
- Fluent in English, speaking and writing
- At least 10 years’ experience in the pharmaceutical industry, in operational quality, familiar with different dosage forms, including sterile products.
- Experience with Project Management in the pharmaceutical industry
- Experience in Quality Assurance and Regulatory inspections
- Experience with manufacturing sites and CMOs
- Certified Lead Auditor
- Lean Six Sigma training