CMC QA ASSOCIATE

Planet Pharma; Bedford (MA); On-site; USD 103,000 - 131,000; Full time

Job summary

Planet Pharma is seeking a CMC QA Consultant to support cross-functional teams and assure quality controls for gene therapy programs. The role requires collaboration with Technical Operations, Regulatory Affairs, and external partners to maintain cGMP compliance.

The position involves on-site oversight at the Bedford, MA site, leading QA activities across batch records, deviations, process validation, and tech transfer while ensuring regulatory readiness and quality system integrity.

Qualifications

• Minimum 9 years experience in GMP biopharmaceutical manufacturing.
• Experience with FDA/EMA and ICH guidelines.
• Experience leading investigations into deviations and CAPA.
• Experience authoring/reviewing regulatory submissions and working with QMS.

Responsibilities

• Review and approve batch records, deviations, and quality systems.
• Support process characterization studies and reports.
• Provide QA oversight of process validation and tech transfer activities.
• Review and approve regulatory submissions and responses.
• Support batch disposition and release activities.
• Ensure GMP processes are implemented in QMS for lifecycle activities.

Skills

Project management

Quality Assurance

Regulatory knowledge

GMP experience

Education

BS degree in Engineering/Biotech/Biology/Physical sciences

Job description

Summary

The CMC QA Consultant will report to the Director of CMC QA and be responsible for supporting cross functional team (i.e. PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc) to confirm the appropriate quality as well as compliant controls are in place for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.

Location: Bedford, Massachusetts

Category: Quality and Compliance

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

Target PR Range: 75-95/hr DOE

Job Description

The CMC QA Consultant will report to the Director of CMC QA and be responsible for supporting cross functional team (i.e. PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc) to confirm the appropriate quality as well as compliant controls are in place for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.

In this role, in collaboration with key stakeholders in Technical Operations, Regulatory Affairs and extended Quality (ie. QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO).

• Review and approve batch records, CC, deviations, and other quality systems
• Support review and approval of process characterization studies and associated report
• Provide quality oversight of process performance qualifications and associated studies
• Review and approve process validation protocols and reports (i.e., Mixing validation, hold studies, extractable and leachable, impurity, column storage etc..)
• Review and approve tech transfer plan, report, and associated deliverables
• Author/Review of regulatory submissions and responses
• Review and approve batch records, CC, deviations, and other quality systems
• Support batch disposition and release

Work Model

This is an on-site role at the Bedford site (classified as Core Lab & Ops).

Responsibilities

• Quality Assurance Lead for the cross-functional CMC Sub-Teams
• Provide quality oversight of process performance qualifications and associated studies
• Support review and approval of process characterization studies and associated report
• Review and approve process validation protocols and reports (i.e., Mixing validation, hold studies, extractable and leachable, impurity, column storage etc..)
• Review and approve tech transfer plan, report, and associated deliverables
• Author/Review of regulatory submissions and responses
• Review and approve batch records, Change Controls, Deviations, and other quality systems as needed
• Support batch disposition and release activities internally and at external partners
• Ensure GMP processes are implemented in the Quality Management System (QMS) for clinical and commercial product process lifecycle (e.g. control strategy, technology transfer, process validation lifecycle, continuous process verification)
• Provide oversight to ensure the creation of product specifications, method validation, stability, and comparability assessments for technology transfers are in accordance with global regulatory requirements and internal procedures/policies
• Provide quality support for Quality System records (i.e. Deviations/CAPA/Change Controls)
• Author/review CMC sections of relevant regulatory dossiers and strategize responses to regulatory agency queries and Qualified Person (QP) queries throughout the product lifecycle
• Communicate and promote a culture of quality and operational excellence

Requirements

• BS degree preferably in an Engineering, Biotechnology, Biological/Physical sciences or equivalent.
• Minimum of 9 years experience in a GMP biopharmaceutical manufacturing environment in Technical Operations and/or Quality.
• Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines and industry best practice.
• Experience supporting authoring/reviewing/approving technical studies
• Experience leading and participating in investigations into manufacturing and analytical deviations and determination of product impact, root cause, and corrective and preventive actions.
• Experience supporting manufacturing operations in a Quality Assurance role
• Experience with performing technical assessment of changes for potential impact to qualification/validation of processes, equipment, utilities, facilities, and systems.
• Capability of collaboratively engaging with CMO’s.
• Experienced in all phases of biologics, gene therapy, and/or cell therapy drug development.
• Demonstrated high personal and professional ethical standards.
• Possesses excellent judgement with the ability to think and act quickly. Must be able to identify creative solutions to complex technical problems.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to communicate clearly and professionally both in writing and verbally.
• Strong organizational and project management skills with a track record fo meeting goals/objectives.
• Strong experience with regulatory authority inspections, including FDA and EMA.
• Travel may be required when appropriate (approximately 10%).
• Expert knowledge of cGMP compliance regulations and industry practices for US/Ex-US

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.