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

BAKKAVOR USA

Regulatory Food Technologist Job at BAKKAVOR USA

 ...infrastructure are vast. 2021 performance has been excellent with even bigger expectations for 2022. Regulatory Technical Services Technologist SUMMARY This person is responsible for supporting Bakkavors and Customer technical product information. Regulatory... 

InRhythm

Lead Product Designer (3 month Contract) Job at InRhythm

 ...Who Is InRhythm? InRhythm is a leading modern product consultancy and digital innovation firm with a mission to make a dent in the digital economy. Founded in 2002, InRhythm is currently engaged by Fortune 50 enterprises to bring their next generation of digital products... 

Holbrook Heating Inc

Customer Service Representative Job at Holbrook Heating Inc

 ...Description: Launch Your Career at Holbrook Heating: Inside: Customer Service Representative Do you thrive in a fast-paced environment and enjoy building positive customer relationships? Holbrook Heating is looking for passionate and detail-oriented individuals... 

U.S. Tsubaki Power Transmission, LLC

Production Operator (UH) - 2nd Shift Job at U.S. Tsubaki Power Transmission, LLC

Description: The TSUBAKI name is synonymous with excellence in quality, dependability, and customer service. U.S. Tsubaki is a leading manufacturer and supplier of power transmission and motion control products. As a part of a vast, international network of corporate...

Novastar Prep Tutoring

Academic Advisor (Remote - Full-Time) Job at Novastar Prep Tutoring

 ...schedule effectively Work Environment & Schedule This is a full-time, remote position with a flexible schedule. You'll work from home, engaging with families via phone, email, and video conferencing. While the role involves extended screen time, we prioritize the...