Associate Director, Quality Assurance (Medical Device)
BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for an Associate Director, Quality Assurance to work for a leading Bay Area biotechnology company.
Associate Director, Quality Assurance
Manage and implement quality assurance programs.
- Oversee assigned quality assurance activities related to FDA regulations and ISO standards for medical devices, pharmaceuticals, and biologics.
- Perform supplier quality audits and facilitate corrective actions.
- Interact with suppliers on quality matters.
- Review/approve validation protocols and reports
- Conduct internal audits/inspections of regulated in-house operations.
- Host/support inspections of facilities and contract organizations by national and international regulatory agencies and notified bodies.
- Identify, organize and adapt implementation of new state/local/federal/international regulations and standards.
- Identify compliance weaknesses and ensure the implementation of workable solutions.
- Audit study reports and raw data for compliance with protocols, SOPs and regulations.
- Audit manufacturing and QC records/documentation.
- Regularly interact with management regarding quality matters and communicate compliance requirements at all levels.
- Provide training and guidance in the areas of government regulations to effected employees.
- Proactively communicate concerns and/or risks to manager or Sr. Management when appropriate.
- Establish and maintain collaborative relationships with cross-functional teams.
- Supervise or provide guidance to lower level staff.
- Perform other related duties as required.
- BS degree in a life science discipline, and a minimum of 7 years of relevant QA experience in the medical device industry; to include previous supervisory or management experience.
- In-depth knowledge of FDA, GMP and GLP regulations (GCP, MDD and ISO compliance experience is a plus).
- Ability to exercise independent judgment and select methods and techniques for obtaining solutions.
- Strong data review and technical writing skills.
- Proven ability to collaborate and work cross-functionally to drive business results in a fast-paced environment.
- Flexible with the ability to effectively manage multiple competing priorities.
- Ability to assess risks and benefits to make timely, sound decisions and accept responsibility for meeting and/or exceeding objectives.
- Experience managing projects with demonstrated organizational skills.
- Demonstrated strong customer focus ability with internal and external customers.
- Strong experience with auditing techniques and evidence development. CQA preferred.
- High-level understanding of scientific approach and analytical thinking of others.
- Ability to travel domestically and internationally.