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

LHH

Administrative Assistant Job at LHH

 ...Administrative Assistant Property Management Background Location: On-site- Arcadia, CA Position Summary: We are seeking a highly organized and detail-oriented Administrative Assistant to support corporate office operations within the property management industry... 

J&H Janitorial Company LLC

Cleaner - Birmingham, AL - Part Time Evening Shift Job at J&H Janitorial Company LLC

 ...Part-Time Cleaner Job Summary The Cleaner performs cleaning and general upkeep of an assigned area. Job Duties Cleaners are...  ...stand, walk, bend, and lift up to 25 lbs for the duration of the shift. Must be able to successfully pass a background check and... 

Sky Land and Ocean Travel

Remote Entry-Level Hotel Coordinator Job at Sky Land and Ocean Travel

 ...customer-focused Entry-Level Hotel Coordinator to assist with booking accommodations and managing hotel arrangements for clients. This remote position is ideal for individuals who enjoy planning, have strong communication skills, and are passionate about hospitality and... 

The Intersect Group

Senior Finance Manager Job at The Intersect Group

 ...Were looking for a Senior Manager, Corporate Finance to lead capital and liquidity management, elevate long-term strategic planning, and serve as a trusted partner to our lending institutions. This high-impact role partners daily with accounting, treasury, analytics... 

Medix™

Call Center Supervisor - 249488 Job at Medix™

 ...Patient Support Center Supervisor Location: Overland Park, KS Schedule: Monday...  ...training, and managing staff ~20% taking calls to assist with volume or process auditing...  ...center environment. Background in healthcare or medical collections. Why Join Us:...