Vice President of Quality
GxPeople is currently working with a global client who is seeking a Vice President of Quality to join their team in Germany.
The Vice President of Quality is responsible for overseeing all GxP (GMP, GCP and GLP) functional areas, ensuring quality oversight and compliance in all GxP related efforts, with a particular emphasis in providing strategic and tactical leadership to the company’s Quality organisation.
- Supervise and manage all GxP Quality tasks.
- Establish a culture of compliance and collaboration by putting Quality processes in place.
- Adhere to company SOPs and other regulatory requirements by assisting with planning, scheduling and carrying out both external and internal GxP audits and inspections
- Establishing and maintaining a good relationship with the regulatory authorities.
- Lead the development of pharmaceutical quality systems – aligning policies, processes and procedures with internal and outsourced activities.
- Assure that manufacturing activities and product testing are appropriate, conducted in compliance with company policies and procedures and that documentation is accessible and ensures traceability/accountability.
- Ensure that Quality agreements are complete, approved and updated at appropriate intervals.
- Oversee risk assessments to determine level of compliance risk. Lead implementation of appropriate risk mitigation strategies.
- Provide guidance for investigations as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations.
- Support development of company training programs for GxP-related procedures, practices and system requirements.
- Manage process improvements for quality information management system.
- Remain current with quality management trends. Review and interpret new regulations, and ensure that the company’s quality systems evolve accordingly.
- Prepare and manage department operating plans and budgets.
- Oversee hiring of staff as well as external consultants, training and mentor staff.
Qualification and Experience
- Bachelor’s degree in biopharma or related field.
- Must have a minimum of 15 years of experience in pharmaceutical/biotech industry with increasing responsibilities, including 5+ years leading a Quality function for both development and post-approval activities.
- Experience overseeing product approval (NDA or BLA) essential; i.e., transition from product development to commercial quality systems and operations.
- Experience establishing and/or enhancing development and commercial GxP quality infrastructure and systems compliant with U.S. and international requirements and a successful track record managing U.S. and international pre- and post-approval inspections.
- Extensive knowledge of GMP, GCP and GLP including 21 CFR Part 11
- Proven track record in establishing and managing GMP/GCP Quality staff.
- Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
- Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical, commercial and operations staff.
For more information or, if you’d like to be considered for this position please call us on +44 20 3637 4393 or email firstname.lastname@example.org.