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Quality Assurance Manager (Biotech/Pharmaceutical Industry)

Yoh, A Day & Zimmermann Company
Cambridge, MA Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/18/2025

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.
  • EDUCATION : BS Degree in life sciences, engineering or related field

    Estimated Min Rate : $350

    Estimated Max Rate : $52.20

    Note : Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

    Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    Visit to contact us if you are an individual with a disability and require accommodation in the application process.

    For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

    Salary : $50 - $52

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