Quality Assurance Biologics Manager
Our client, a distinctive and rapidly growing pharmaceutical company, is looking to add a Quality Assurance Biologics manager to their team. Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations of biosimilar products.
Essential Duties and Responsibilities:
- Working across functions, lead the establishment and maintenance of the site’s quality systems related to biological/biosimilar manufacturing operations and packaging to enable the development and reliable supply of medications to patients.
- Responsible for quality oversight of clinical trials.
- Responsible for all operational compliance aspects of sterile fill finish manufacturing of biological/biosimilar products including but not limited to batch record review and batch release.
- Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products at the site comply with company and relevant cGMP regulatory requirements.
- Ensure Standard Operating Procedures and training is in place to maintain compliance with cGMP.
- Provide leadership, direction, and support to the people within the Quality Assurance Operations department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
- Maintain current knowledge of local and international biologics regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
- Support and ensure compliance of biological/biosimilar products and process transfers, including validation from and/or to other manufacturing sites.
- Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Participate in or lead quality risk analysis.
- Travel (up to 10%) may be required.
Basic Qualifications and Capabilities:
- Bachelor’s degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry.
- Experience in biological and combination products (i.e. pre-filled injectable pens)
- Experience in sterile injectable manufacturing and packaging operations is required.
- Quality assurance experience across the product development and commercialization lifecycle including change management and associated implementation strategies.