The Senior Supplier Quality Specialist is responsible for maintaining compliance of Quality Systems utilized to manage Externally Manufactured products and processes throughout the product lifecycle, including development, manufacturing, and post-market in an RX, OTC, Cosmetic and Medical device regulated environment.
- Coordinate and lead EMQA personnel and business stakeholders through the change management system
- Chair Material Review Board, Local Change Board, and CAPA review committee meetings as required
- Support CMO manufacturing in improvement of processes, resolution of non-conformances, maintenance/ improvement of quality system.
- Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls. Uses relevant statistical tools to analyze data for proactive improvements.
- Identify areas of systemic weakness, and leads initiatives to implement corrective action. Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions.
- Provide routine analysis of Quality Performance indicators (NCs, CAPAs, QCRs Complaints, etc.). Presents this information to Senior EMQA, Supply Chain and CMO management as required. Leads quality initiatives to improve performance.
- Leads teams to develop risk management files & PFMEAs for new processes and process changes. Focus team on implementing capable processes, process controls, and error-proofing measures.
- Leads process improvement teams across CMO sites to drive compliance improvements, as well as standardization across the sites.
- Provide direction to EMQA personnel to facilitate the resolution of non-conformances, using root cause analysis tools, and proposing/implementing systemic corrective actions.
- Review and update departmental procedures
- Review quality management documentation including non-conformances, CAPA, and quality change requests
Scope of Position:
Primarily supports Bausch Health Contract Manufacturers. May be requested to support other BHC/Bausch & Lomb facilities as needed.
Supervisory experience in a Quality Operations role preferred.
Internal: Functional representatives within BHC/Bausch + Lomb facilities.
External: Suppliers, external auditors/regulatory authorities, and customers.
- BS Engineering or Technical Field.
- Knowledgeable of ISO 9001/ISO 13485 and FDA/QSR requirements and quality system development and management. Medical Devices and/or Pharmaceutical manufacturing experience required. Knowledgeable of statistical techniques and application experience. Demonstrated project management and leadership skills, strong written and oral communication and interpersonal skills.
- ISO 13485, ISO 9001, GMPs, MDD required. CMDR, JPAL, ISO 14001, OHSAS 18001, and other regulations are desired. Working knowledge of FDA regulations and experience with managing external agency audits necessary.
- Training and experience in validation, auditing, statistics preferred. Certified ASQ CQE and/or Lean Six Sigma Green belt preferred.
- Training in problem solving tools is required (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis),
- Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio , statistical software usage & principles.)
7-10 years quality experience, 5 years minimum in pharma or medical devices.