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

Hilton

Security Officer - Embassy Suites by Hilton Miami Airport Job at Hilton

 ...Embassy Suites by Hilton Miami Airport is looking to welcome a Security Officer to join their team! The ideal candidate holds a minimum of 6 months experience...  ...: Quality Productivity Dependability Customer Focus Adaptability What will it be like to work... 

Marketech International Corporation

Logistics / Warehouse Manager Job at Marketech International Corporation

 ...We are seeking an experienced Logistics Manager to oversee and optimize material management, warehousing...  ...teams to align material demand and supply. Warehouse & Logistics Operations...  ...~ Bachelor's degree in Supply Chain Management, Logistics, Business, or a related... 

Pride Health

Progressive Care Nurse Job at Pride Health

Pride Health is hiring RN PCU to support our clients medical facility based in Aurora, Colorado. This contract opportunity is a great way to start working with a top-tier healthcare organization! Minimum Qualifications Education: BSN required Licensure...

Wexford Health Sources

Substance Abuse Counselor Job at Wexford Health Sources

 ...POSITION: Substance Use Disorder Counselor NMCD SCHEDULE: Opportunities available for day, evening, and night shifts FACILITY: The Penitentiary...  ...Currently licensed as Licensed Independent Substance Abuse Counselor (LISAC), Licensed Associate Substance Abuse... 

Insight Global

Maintenance Manager Job at Insight Global

 ...Day to Day: Insight Global is hiring a Helicopter Maintenance Control Representative to support our client in Malmstrom AFB, MT. The...  ...assigned aircraft, certify Aircraft/Engine Logbook entries, and manage maintenance control responsibilities. Candidates must possess...