Manager Quality Assurance Operations (Contractor)
Job Description
R&D Partners is seeking to hire a Manager Quality Assurance Operations (Contractor) in Cambridge, MA.
Your main responsibilities as a Manager Quality Assurance Operations (Contractor):
Execute quality oversight of external manufacturing of both clinical and commercial drug product through lot disposition
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
What we are looking for in a Manager Quality Assurance Operations (Contractor):
Minimum BS degree in life sciences, engineering or related field.
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.
Experience with aseptic techniques and supporting parenteral drug manufacturing operations.
Experience of first hand GMP management is essential, and will include exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing.
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
Pay Scale:
$86,960 $108,700 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
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