Location: Netherlands (Hybrid)
Overall Job Purpose:
The CMO QA Manager is responsible for ensuring compliance with the company’s Biologicals products manufactured externally, and worldwide. This includes support on product development and commercial operations, in addition, to ensure the on-time release of the product under the release responsibility of the external CMO group plus appropriate maintenance of local quality systems. He/she ensures that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement and Regulatory expectations. Supports the QMS that consolidates Health Authority Regulations into the company’s Quality requirements for Biologic products.
Major Responsibilities:
- Management (Initiates, investigates, and ensures timely closures) of key quality systems including deviations, change controls, CAPAs, and complaints associated with the products, by liaising with CMOs, QA Manager/QP, operations, QC, and company’s other stakeholders associated with Drug Substance/API, Drug Products or Medical Devices appropriately and in a timely fashion.
- Review of CMO documentation to ensure compliance with GMP and with the marketing authorizations as well as applicable and correct documentation for release (CoA, CoC, etc.)
- Lead and organize periodic quality meetings to evaluate the status and timely closing of Change Controls, Deviations, and CAPAs with CMOs, internal departments (QP, Supply Chain, and RA), process, and product-related.
- Supports technology transfers and process/ analytical method validation activities from a quality operations perspective when required.
- Support the preparation of annual product reviews (APR/PQR) of Branded products
- Manages and maintains product specifications in accordance with current marketing authorizations and ensures timely updates of applicable associated documentation in support for batch release.
- Responsible for receiving, managing, and tracking CMO change notifications, performing timely communication with both internal and external internal stakeholders according to the requirements of Quality Agreements.
- Ensures the comprehensive use of risk management tools in aspects across the quality management system, and product-related elements to assess the impact on product quality, and overall compliance with regulatory expectations and with marketing authorizations.
- Works closely with the Quality System Manager to support the QA IT systems and act as a back-up for QA IT systems activities.
- Support the timely implementation of global standards and procedures by execution of associated GAP assessments against local procedures.
- Support the maintenance and update of the Quality Management System.
- Support planning and inspection readiness for external audits (from partners, Corporate Quality Systems, and regulatory authorities
Education Qualifications (Graduate- Post Graduate):
- HBO or Bachelor’s Degree in (Bio-) Chemistry, Pharmacy, Biotechnology, or similar education.
- Minimum of 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
- Strong knowledge of EU GMP, and US CFRs.
- Well-versed in Microsoft Excel.
- Fluent in English
Work experience (Must Have):
- Tenure: minimum 5 years
- Industry: (Bio) pharmaceutical, sterile manufacturing
- Content areas: Manufacturing, QA /QC. QA manufacturing operation.
Technical Competencies
- Experience in preparation of the batch release, including batch documentation review and preparation for batch certification.
- Strong cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU, and other international agencies)
- Advanced knowledge and experience in API/DP biopharmaceutical operations, QA/QC processes, and contract manufacturing.
- Good understanding of complex change control processes and interaction with regulatory affairs processes.
- Good understanding of regulatory submission processes.
- Capable of reviewing and assessing manufacturing and analytical technical documents and providing sound quality assessments on change controls, deviations and complaints.
- Experience working with electronic Document Management, electronic Training systems and Track-wise
- Understanding of risk assessment and risk management fundamentals/tools
- Experience interacting with external parties.
- Good knowledge of MS office and Windows-based computer applications.
Behavioral Skills/Competencies:
- Strong interpersonal skills, excellent communication skills, good presentation, negotiations, and influencing skills
- Ability to effectively manage multiple, complex priorities and quick shifting of those.
- Team player, task-oriented, and keen on working in a cross-cultural working environment.
- People oriented with the tendency to help others and go beyond her/his area of responsibility.
