Quality Assurance Manager (Biotech/Pharmaceutical Industry)

Category:

Life Science

Employment Type:

Contract To Hire

Reference:

BH-381509

Quality Operations Manager (Biotech/Pharmaceutical Industry Experience)
Contract (11 months) with perm potential
Pay rate: $50 - $52.20 per hour (depending on experience)

Location: Cambridge, MA: Hybrid 2 or 3 times per week onsite preferred but the hiring manager is open to remote EST time zone.

***This role requires A minimum of 5 years of experience in a pharmaceutical or biopharmaceutical company in roles of increasing responsibility in Quality Assurance. Experience working with external contract manufacturing organizations in a virtual setting is also required along with supporting all GMP aspects of drug product manufacturing.

***Experience working with investigational and commercial products in a Quality Operations role is preferred.

Other Experience / Responsibilities:

• Providing oversight to ensure clinical through commercial lifecycle activities meet the cGMP regulatory requirements and guidelines
• Experience with aseptic techniques and supporting parenteral drug manufacturing operations.
  
• Execute quality oversight of external manufacturing of both clinical and commercial drug product through lot disposition
• Experience of first-hand GMP management is essential, and will include exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing.
  
• Experience working with Alliance Partners is preferred.
  
• Provide QA review and approval of internal and external Deviations, Change Controls, CAPAs.
• Provide QA support for review and data verification of clinical regulatory filings
• Engage with alliance partners to assure compliance to their quality systems and practices as related to manufacturing through disposition of drug product.
• Support establishment of best practices with alliance partners
• Collaborate and support internal colleagues and external vendors to navigate complex quality issues, ensuring compliant solutions are explored and meet patient needs.
• Ensure timely and accurate metrics reporting for KPI and risk register tools
• Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.