Job Title: Manager Quality Assurance & Compliance
Description: Our client company is an exciting, well funded, clinical stage specialty pharmaceutical company that designs, develops, and commercializes prescription pharmaceuticals for conditions associated with chronic kidney disease, endocrine, cardiovascular, and bone & mineral diseases. Assume a key leadership role, reporting to the Director Quality Assurance, and managing all quality assurance, technical services, and document control functions with excellent career growth prospects.
- Manage all quality assurance, technical Services, and document control functions.
- Provide direction and influence for the development/implementation of all quality systems and programs.
- Manage the quality audit function and assure the effectiveness of the corrective and preventative action (CAPA) processes within the quality management system.
- Assure that products manufactured conform to the intended product design and specifications.
- Review quality assurance studies and best practices to improve the quality of processes and products.
- Oversee the approval or rejection of all components, container/closures, in-process materials, packaging material, labeling, and drug product and the vendor interactions to support these activities.
- Oversee the review of production records, specification and CoA.
- Ensure that contractors, vendors and consultants used in regulated activities are appropriately trained and qualified.
- Assist in the management of Quality Assurance audits for compliance with GCP, GMP and GLP requirements (Internal & External), communicate findings and coordinate corrective and preventative action plans across stakeholder community.
- Manage the review, investigation and follow-up on non-medical complaints.
- Proactively promote cross discipline and functional teamwork, and quality culture throughout company.
- Provide quality assurance expertise to company personnel and senior management/executives.
- Perform other duties as assigned or required to perform the duties associated with position.
- Extensive knowledge of quality assurance requirements regarding the development, testing, release, and distribution of marketed and/or investigational drug products in the US, Canada and the EU.
- B.S. degree in a scientific discipline.
- Minimum 2 years in a manager position with drug development and/or commercial stage pharmaceuticals.
- Solid knowledge of GCP, GLP, GMP requirements.
- Superior management, analytical, strategic, decision making, interpersonal and mentoring skills.
- Proven track record of building effective internal and external relationships.
- Ability to work effectively with cross-disciplinary teams and with vendors.
If this opportunity does not meet your needs but you know someone qualified, please refer this opportunity to them. Refer This Opportunity to a Colleague.