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About this Job
Location: Bedford, MA (Onsite)
Length: 6+ Month Contract
Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available
Job Description:
This role provides quality oversight and guidance across the clinical through commercial development lifecycle for drug substance and drug product activities, including work performed at company sites and with external contract manufacturing organizations.
The consultant will collaborate with key stakeholders in Technical Operations, Regulatory Affairs, and extended Quality teams, including QC and Supplier Quality, to help ensure cGMP requirements and applicable guidelines are met. The role also supports process improvement efforts to strengthen product quality and operational excellence.
Essential Duties and Responsibilities:
- Serve as the Quality Assurance lead for cross-functional CMC sub-teams.
- Provide quality oversight of process performance qualifications and related studies.
- Review and approve process characterization studies and associated reports.
- Review and approve process validation protocols and reports, including mixing validation, hold studies, extractable and leachable studies, impurity studies, and column storage studies.
- Review and approve tech transfer plans, reports, and associated deliverables.
- Author and review regulatory submissions and responses.
- Review and approve batch records, change controls, deviations, and other quality system records as needed.
- Support batch disposition and release activities internally and with external partners.
- Ensure GMP processes are implemented in the Quality Management System for the clinical and commercial product lifecycle, including control strategy, technology transfer, process validation lifecycle, and continuous process verification.
- Provide oversight to ensure product specifications, method validation, stability, and comparability assessments for technology transfers are developed in accordance with global regulatory requirements and internal procedures and policies.
- Provide quality support for Quality System records, including deviations, CAPAs, and change controls.
- Author and review CMC sections of regulatory dossiers and help develop responses to regulatory agency and Qualified Person queries throughout the product lifecycle.
- Communicate and promote a culture of quality and operational excellence.
Qualifications:
- Bachelor’s degree in Engineering, Biotechnology, Biological Sciences, Physical Sciences, or a related field, or equivalent experience.
- Minimum of 9 years of experience in a GMP biopharmaceutical manufacturing environment in Technical Operations and/or Quality.
- Strong working knowledge of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines, and industry best practices.
- Experience authoring, reviewing, and approving technical studies.
- Experience leading and participating in investigations into manufacturing and analytical deviations, including product impact assessment, root cause analysis, and CAPA determination.
- Experience supporting manufacturing operations in a Quality Assurance role.
- Experience performing technical assessments of changes for potential impact to qualification and validation of processes, equipment, utilities, facilities, and systems.
- Ability to work collaboratively with contract manufacturing organizations.
- Experience across all phases of biologics, gene therapy, and/or cell therapy drug development.
- Demonstrated high personal and professional ethical standards.
- Strong judgment and the ability to think and act quickly, including identifying creative solutions to complex technical problems.
- Ability to interpret and apply quality standards in implementation and review activities.
- Strong written and verbal communication skills.
- Strong organizational and project management skills with a track record of meeting goals and objectives.
- Strong experience with regulatory authority inspections, including FDA and EMA.
- Travel may be required, approximately 10%.
- Expert knowledge of cGMP compliance regulations and industry practices for US and ex-US markets.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Come see why DPC has achieved:
4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
Voted ‘Best Staffing Firm to Temp/Contract For’ 8 consecutive years in a row by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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