Note: No C2C.
Job Description:
- Bachelor's degree in Science required. Preferably in Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.
- At least 5 years' experience within a highly regulated field. Preferably in Medical Device or Pharmaceutical Industry supporting Regulated Products.
- Experience in GMP guidance, medical device, including 21 CFR Part 11 required.
- Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
- Knowledge, Skills, Abilities Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.
- Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.
- Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
- Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
- Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001/13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
- Quality tools e.g. Root Cause Analysis, Risk Assessment.
- Global Systems e.g. TrackWise, OCPLM, E1, LIMS
- Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (OCPLM, Trackwise, LIMS, Master Control, ERP, etc.).
Knowledge, Skills, Abilities (Preferred):
- Experience with biological manufacturing processes.
- Project Management advanced experience.
- Certified Lean Professional or Six Sigma
