What are the responsibilities and job description for the Manager of Quality Systems position at Tobin Scientific?
About Tobin Scientific
Tobin Scientific is a leading provider of cold chain, ambient storage, and transport & logistics services for the biopharma industry, and is one of the fastest growing companies in Massachusetts. Serving a diverse array of clients in life sciences, university, government, and more, we're recognized for our expertise in ensuring the safety and security of temperature-sensitive products during transport and storage. Our cGMP storage solutions are custom-built for the pharmaceutical and biotech industries, managing mission-critical consumables, equipment, raw materials, and finished goods with precision. Nationally acclaimed for laboratory relocation, principal investigator support, and other logistics services, Tobin Scientific's holistic approach and commitment to excellence make us an integral player in life science services.
We are seeking a Manager of Quality Systems to drive our quality assurance initiatives and maintain compliance with industry standards. This role offers an exciting opportunity to contribute to our growth while ensuring operational excellence across our sites. Working directly with senior leadership, this person will have the flexibility to make an impact at Tobin Scientific while working in a collaborative environment.
Responsibilities
- Quality Systems Management:
- Oversee training programs and ensure compliance.
- Manage internal audit program.
- Supervise supplier qualification lifecycle.
- Provide support for audits and inspections as needed, including certifications such as ISO9001.
- Manage document control processes:
- Periodic review and updates (as a quality reviewer), metadata review, document review, etc.
- Maintain electronic quality management system.
- Commissioning, Qualification, and Validation (CQV)/CSV:
- Review and approve CQV and CSV documents.
- Maintain and oversee the validation schedule.
- Operational Support:
- Ensure on-site presence for quality assurance.
- Perform log reviews, audit trail reviews, and business continuity testing.
- Support quality events and change management processes.
- Assist in onboarding new sites as needed.
- Provide general support to the quality function and Head of Quality.
Qualifications
Required:
- Based in the Boston area with the ability to be on site at multiple locations throughout the north shore/Greater Boston area.
- Education: Bachelor's degree in Life Sciences, Engineering, or equivalent.
- 3-5 years of experience in a quality assurance or quality systems management role, preferably in a GMP-regulated industry (pharmaceuticals, biotech, medical devices, etc.).
- Strong analytical, problem-solving, and organizational abilities.
Preferred:
- Familiarity with ISO 9001 standards.
- 3-5 years in a GMP quality function.
- Knowledge of 21 CFR Part 11 and Part 211 compliance.
- Experience in QC, medical device or related areas.
- Exposure to internal and external audits.
- Familiarity with validation processes (CQV/CSV) and supplier qualification lifecycles.
Disclaimer: Tobin Scientific is an Equal Opportunity Employer practicing non-discriminatory recruitment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This job description provides an overview of the responsibilities and duties expected for this position. It's not exhaustive, and personnel may be asked to perform duties outside their typical responsibilities
