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

Insight Global

Welder Job at Insight Global

 ...tolerances according to specifications. Skill in welding dissimilar metals. Competence in welding parts and structures of varying...  ...experience Job Description Perform welding and fabrication tasks on marine vessels and components in accordance with NAVSEA... 

Scott Humphrey Corporation

Travel Construction Superintendent Job at Scott Humphrey Corporation

 ...We are seeking an experienced Construction Superintendent to oversee multiple Quick Service Restaurant (QSR) projects across the region. This is a travel-intensive role requiring hands-on leadership, project management, and strong subcontractor coordination to ensure... 

luckyscent

Graphic Designer Job at luckyscent

About Us Since 2002, Luckyscent has been the playground for perfume lovers who refuse to smell like everyone else. We scout the globe for niche, rare, rule-breaking fragrances and bring them to our community through our online store and our boutiques in NYC, Hollywood...

Logenix International

Logistics Coordinator Job at Logenix International

 ...Company Description: Logenix International is a distinguished logistics provider specializing in humanitarian aid, disaster relief, development infrastructure, global health programs, and high-profile U.S. Government-funded projects. Over the past 20 years, Logenix has... 

Stoneridge at Centerra

Housekeeper/Laundry Aide Job at Stoneridge at Centerra

 ...Employee Assistance Program Our community is looking for a Housekeeper to join our team. Housekeeper Responsibilities:...  ...Responsible for collecting, cleaning and redistributing the community laundry. Responsible for maintaining the commercial laundry in a...