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

Nelson Lumber & Home Inc

Kitchen and Bath Salesperson Job at Nelson Lumber & Home Inc

Be an Owner, Not Just an Employee Join Our Team in Hayward! Help Wanted: Kitchen Cabinet / Bath / Flooring Specialist The Floor to Ceiling Store Hayward, WI The Floor to Ceiling Store in beautiful Hayward, WI is growing, and were looking for a full-time Kitchen...

NX Direct

Junior Account Manager Job at NX Direct

 ...solid business relationships on behalf of some of the most well-respected brands in technology throughout the world. They link a customer's needs with the solutions and products available to them, providing a consultative sales approach that focuses on value and problem... 

KYOCERA AVX Components Corporation

Control System Engineer Job at KYOCERA AVX Components Corporation

 ...Position Summary: The Equipment Controls System Engineer is assigned to improve equipment controls systems and to integrate equipment controls systems with higher level production and quality control software systems. Responsible to support the Kyocera AVX initiative... 

Marshall Industrial Technologies Inc.

Sales Manager Job at Marshall Industrial Technologies Inc.

 .../7 availability, our team is dedicated to meeting the needs of businesses around the clock. Role Description This is a full-time, hybrid location Sales Manager role based in Trenton, NJ and Stockertown, PA. Experience with Mechanical, Electrical, HVAC/R and/or... 

DYNE Hospitality Group

Tropical Smoothie Cafe - Team Member (TX046) Job at DYNE Hospitality Group

Location: 760 Airport Fwy Suite 400 Hurst TX 76054 Work Week : Flexible hours are available! Able to work starting at 5:00 AM or until midnight if required, based on caf hours and availability. Welcome to the DYNE Hospitality Group (Tropical Smoothie Caf...