CyberCoders Quality Assurance, Sr. Manager / Associate Director, GMP Biotech in Waltham, Massachusetts

Quality Assurance, Sr. Manager / Associate Director, GMP Biotech Quality Assurance, Sr. Manager / Associate Director, GMP Biotech - Skills Required - Quality Assurance, GMP, GCP, CAPAs, Batch Records, Working with CMOs, Validation, Audits, Pharmaceuticals, Combination Devices

Based just outside of Boston in Waltham, we are an emerging clinical-stage biopharmaceutical company. If you're an Associate Director, Quality Assurance or Senior Manager, Quality Assurance, please read on!

Not for you? Refer a friend and get a $100 REFERRAL BONUS-!

Top Reasons to Work with Us

  • Huge potential to build out the quality function

  • 4 promising programs in pipeline

  • Recent FDA and EMA fast-track designation

  • Multiple therapeutic areas

  • Excellent funding

  • Incredible team of 8 in our Waltham location

  • Agile company of 25 employees helps us make decisions quickly

What You Will Be Doing

We are looking for someone with ample pharmaceutical GMP quality assurance experience to build out and drive our quality function as we gear-up for the clinic and FDA approvals of a parenteral drug product. You will be hands-on, reporting to the VP of Regulatory Affairs and Quality Assurance, to grow the quality function internally and to ensure our CROs and external vendors are audit-ready. This will include reviewing master batch records, writing SOPs, training our team, implementing compliance systems, validation, and more.

Please apply for additional details on our technology/etc.

What You Need for this Position

  • Strong knowledge of GMP in a pharmaceutical, Phase I-III environment

  • Knowledge of US & EMA &ICH regulations/guidance for CMC and GMP

  • Ability to manage processes and work hands-on as needed

PREFERRED

  • GCP and GLP knowledge

  • Phase IV / Commercialization experience

  • Medical Device or Parenteral / Combination Device Experience

  • M.S. or Ph.D. within related area of study

What's In It for You

Potential to work from home every once in a while as needed

Competitive Salary

Great Benefits

Generous PTO/Vacation

Seminars, Training and Professional Development

Advancement Opportunities

Paid Holidays

Direct Deposit

So, if you are an Associate Director or Senior Manager of Quality Assurance with experience, please apply today!

Not for you? Refer a friend and get a $100 REFERRAL BONUS- if s/he is hired!!

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Quality Assurance, Sr. Manager / Associate Director, GMP Biotech MA-Waltham NN1-1379968