Details:

Title: Quality Assurance Operations Manager

Location: Cambridge, MA - Hybrid 2-3x per week onsite preferred.

Duration: 12 months

?Overview The Ma

nager of Quality Assurance Operations will work within the DP / CMC / Alliance QA Operations team and is responsible for providing support to all GMP aspects of drug product (DP) manufacturing, CMC and alliance management. This role will work cooperatively with their counterparts in Quality Operations to provide quality oversight to ensure clinical through commercial lifecycle activities meet cGMP regulatory requirements and guidelines. This position reports to the Director of Quality Assurance.Key Re

sponsibilitiesExecut

e quality oversight of external manufacturing of both clinical and commercial drug product through lot dispositionProvid

e QA review and approval of internal and external Deviations, Change Controls, CAPAs.Provid

e QA support for review and data verification of clinical regulatory filingsEngage

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 partnersCollab

orate 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 toolsRespon

sible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.Qualif

icationsMinimu

• m BS degree in life sciences, engineering or related field.A mini
• mum of 5 years of experience in a pharmaceutical or biopharmaceutical company in roles of increasing responsibility in Quality Assurance.Experi
• ence working with external Contract Manufacturing Organizations in a virtual setting.Experi
• ence with aseptic techniques and supporting parenteral drug manufacturing operations.Experi
• ence of first hand GMP management is essential, and will include exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing.Experi
• ence working with investigational and commercial products in a Quality Operations role is preferred.Experi
• ence working with Alliance Partners is preferred.Experi
• ence driving out inefficiencies and improving turnaround times.Locati

on: Cambridge, MA - Hybrid 2-3x per week onsite preferred Bachel

or degree requiredSkills

et - Not lo

oking for entry level candidate, seeking someone with 5-7 years of experience within supporting QA operations and experience with batch documentation, batch disposition, System

s: Veeva Quality and SAPNot a

systems role, it is operations focusedRegar

d

s, Himani