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

The Staff Pad

Brand Ambassador Job at The Staff Pad

 ...Position Overview We are seeking a professional, outgoing Brand Ambassador to represent our commercial roofing company across industry...  ...networking mixers). Reliable transportation and ability to travel locally and regionally for events. Professional... 

Pyramid Consulting, Inc

Digital Marketing Specialist Job at Pyramid Consulting, Inc

 ...Immediate need for a talented Digital Marketing Specialist. This is a 06 months contract opportunity with long-term potential and is in Mountain View, CA(Hybrid) . Please review the job description below and contact me ASAP if you are interested. Job Diva ID:... 

Korn Ferry

Finance Manager Job at Korn Ferry

 ...high-quality, patient-centered care across a variety of clinical disciplines. We are seeking an experienced and detail-oriented Finance Manager to join our leadership team and support the continued expansion and operational excellence of our organization. Position... 

Tal Healthcare

Director of Clinical Services - Substance Use Disorders (MSW, LCSW, LMSW, LMHC, LMFT, or CASAC) Job at Tal Healthcare

 ...client, a leading provider of inpatient substance use treatment, is hiring a Director of...  ...programs Supervise and grow a team of counselors and incoming peer recovery staff Oversee...  ...compliance with OASAS, JCAHO, and internal standards Collaborate with admissions... 

HirePower

Patient Care Specialist Job at HirePower

 ...are looking for individuals to join our clients team as Patient Care Specialist in the Labor & Delivery department. You will be working under direct supervision of a licensed Nurse or other professional medical staff in a health care setting. The right person will be comfortable...