Purpose and Scope of Position:
The Senior Director, Head of Site Quality Operations, is accountable for the Quality oversight of manufacturing Operations. This role also is accountable for the QA operations, QC operations and the compliance of the site. This position will ensure Site operations comply with regulatory requirements and adopt effective and efficient industry standard practices and will provide direction of both the QA and QC units accordingly.
Required Competencies: Knowledge, Skills, and Abilities
- Solid understanding of Oral Solid Dosage, Recombinant, and Sterile products manufacturing, packaging, testing, warehousing processes and validation.
- In-depth knowledge of and thorough understanding of cGMPs and FDA; EU, and Swiss compliance standards, regulation, and guidelines.
- Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.
- Excellent interpersonal, collaborative and organizational skills.
- Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.
- Strong leadership skills for the management of large teams.
- Knowledge of most common office software and of IT-principles.
Duties and Responsibilities
- Ensures that all products manufactured at the site are produced, tested, and released in compliance with SOPs, cGMPs and FDA regulations. Ensures systems, resources, and action plans are reviewed and decisions made to attain sustainable compliance. Makes decisions regarding quality control and compliance for all batches and products, including discrepant batches (investigations, retesting and re-inspections.) Is the primary contact with the FDA field operations and District Office staffs and liaison during FDA inspections.
- Responsible for release of batches manufactured by or under the responsibility of Celgene.
- Responsible for final review and approval of product for release for sale, including batch documentation from contract manufacturers/packagers/laboratories related to Celgene.
- Assures review and approval of batch record documentation including validation protocols, master batch records, analytical test results, packaging and labelling documentation.
- Performs QA reviews and approval of printed materials for products being manufactured by or under the responsibility of Celgene
- Assures that adequate staff, equipment and facilities are available to complete activities for product release within required timelines.
- Assures adequate GMP and related job specific training programs are utilized, and effective, throughout the manufacturing organization.
- Responsible for issuing the Annual Quality Review Report and the Product Quality Review according the Swiss-, EMEA- and FDA-requirements for assigned products.
- Ensures handling and investigation of Celgene Product Quality Complaints in a timely manner (Investigation, solving and closing); prepares quarterly reports on such activity for senior management review.
- Ensures implementation and maintenance of an adequate, state-of-the art quality management system (QMS).
- Assure site readiness for regulatory inspections including providing support for inspection preparation activities in QC and contractor sites, as needed.
- Responsible for the preparation and hosting of Authority Inspections including the organization of the back office.
- Acts as QA representative during pre-approval inspections.
- Directs all operational aspects of the QA and QC operations in support of manufacturing, packaging, testing, warehousing, and releasing activities and Quality Systems definition and management.
- Works closely together with the Head of Manufacturing, MS&T and AS&T and their team to improve systems and processes, to transfer new products and analytical method, and to solve any problems, providing GMP and analytical trouble-shooting support to ensure full alignment of Commercial Product Manufacturing, Testing, and Distribution to comply with business needs.
- Participates in Operations planning process, prepares budgets, recommends capital expenditures for technology and equipment, and allocates resources to support manufacturing, testing, and investigations.
- Identifies best practices both internally and external, through comprehensive bench marking, defines the implementation strategies and roll out.
- Oversees complex investigations / quality manufacturing, packaging, testing, and distribution issues/deviation to analyze and propose corrective actions to prevent reoccurrence and ensure appropriate product disposition.
- Accountable for maintaining quality KPI's/metrics and data for the periodic quality management review.
- Works closely together with the other peers to ensure improvement and alignment of the Quality Management Systems between the Sites.
- Contributes in defining Global Quality System Software requirements, ensures the implementation and maintenance of such a system.
- Accountable for the execution of GMP-audits internally and at selected suppliers/contractor.
- Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility and ensures
- Works closely with EHS to evaluate hazards and perform risk analysis
- Promotes safe practices and behaviors, verify that EHS rules are implemented and respected
Education and Experience:
- 10+ years of experience in Quality Assurance and/or Quality Control in a pharmaceutical company or other related industry.
- Master's degree in Pharmacy, Chemistry, Microbiology or related science or equivalent experience, preferred.