Compliance Specialist

9 Technology Drive Westborough, MA 01581 US

Posted: 10/21/2025 2025-10-21 2025-11-21 Employment Type: Contract Job Category: Quality and Compliance Job Number: 623366 Is job remote?: No Country: United States

Job Description

Purpose and Scope:

The Compliance Specialist will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM. The successful candidate will foster data integrity, quality, and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts to help ensure high quality standards and value delivery for our patients.

Responsibilities and Accountabilities:

Essential Duties and Responsibilities include, but are not limited to, the following:

• Performs QA review of executed GMP analytical batch records; in-process, release, and stability data to ensure compliance with regulatory requirements, internal quality standards, internal procedures, and contribute to the overall Quality Assurance processes.
• Performs QA review of executed development studies intended for regulatory submissions, included but not limited to, draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.

Identifies and reports documentation errors and deviations from test / data records, protocols, Standard Operating Procedures (SOPs), or specifications in a timely manner.

• Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

Required Qualifications:

• BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
• Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).

Preferred Qualifications:

• Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.

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.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

Apply Now:

Apply Online

Apply Later

Send an email reminder to:

Email Address

Share This Job:

Login to save this search and get notified of similar positions.