Quality Assurance Manager Job at Planet Pharma, Cambridge, MA

dE82enZzNWd1a3hjMTNmeWdqT2hET1RuNUE9PQ==
  • Planet Pharma
  • Cambridge, MA

Job Description

Overview

The Manager 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 Responsibilities

  • 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
  • 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.

Qualifications

  • 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.
  • Experience working with investigational and commercial products in a Quality Operations role is preferred.
  • Experience working with Alliance Partners is preferred.
  • Experience driving out inefficiencies and improving turnaround times.

Systems: Veeva Quality and SAP

  • Not a systems role, it is operations focused

Pay Rate: $45-49/hr* Based on Experience

Job Tags

Contract work,

Similar Jobs

Walmart

Pre Grad Intern - Sam's Club Pharmacy Job at Walmart

 ...Excellence: Drives continuous improvements is open to and uses new technologies and skills and supports others through change At Sam's Club, we offer competitive pay as well as performance-based bonus awards and other great benefits for a happier mind, body, and wallet... 

Top Level Promotions

Office Administration - Work from Home Assistant Job at Top Level Promotions

 ...Work from Home Data Entry & Office Administration Remote Online Role About the Job We are seeking motivated individuals in Shreveport...  ..., technology, and Amazon . Flexible scheduling allows part-time or full-time work to suit your availability. Job... 

Mindlance

Senior ETL Consultant Job at Mindlance

Position Details: Title: Lead ETL Developer Duration: 6+ Months (with Possible Extension of 1 year) Location: Boston, MA Work Mode: Hybrid Work hours: 37.5 hours per week Key Responsibilities: Participate in crafting application architecture document...

Michaels Stores

Financial Systems Administrator Job at Michaels Stores

 ...Under general supervision, the Financial Systems Administrator will support the operation of Oracle Cloud ERP and EPM modules. You will focus on the tactical aspects of the Oracle Cloud applications including ongoing strategy for Cloud usage, license management, and... 

Castongia Tractor Crown Point

Lawn & Garden Service Technician & Equipment Delivery Driver Job at Castongia Tractor Crown Point

 ...first-class support, and cutting-edge technology to our partners.Job Summary:We are seeking a Lawn & Garden Service Technician & Equipment Delivery Driver to join our team. This dual-role position is responsible for diagnosing, repairing, and maintaining lawn and...