Manager of Quality Operations

Tobin Scientific•Methuen, MA

17d•$100,000 - $120,000•Onsite

About The Position

The Manager, Quality Operations is responsible for ensuring compliance with Good Manufacturing Practices (GMP) across warehouse and logistics operations. This role provides quality oversight of daily GMP activities, including product handling, storage, and shipment within temperature-controlled environments. The Manager serves as a key liaison between Quality Assurance and Operations, supporting continuous improvement, maintaining compliance, and ensuring the consistent execution of quality standards across all functions. Location: Multiple locations, all located north of Boston, MA, including but not limited to Billerica, Wilmington, and Methuen. On-site requirements will be 4 days a week.

Requirements

2-3 years of experience in Quality Assurance or Quality Operations roles within a GMP-regulated industry (pharmaceutical, biotechnology, medical device, or related field).
Working knowledge of GMP, GDP, and quality system requirements, including deviations, CAPAs, complaints, and change control.
Experience in warehousing or cold chain logistics strongly preferred, including handling of controlled temperature storage environments (-20°C, 2-8°C, and 15-30°C).
Experience working cross-functionally to resolve issues, drive continuous improvement, and support compliance initiatives.
Proficient in the use of electronic Quality Management Systems (eQMS) and other digital tools (e.g. Veeva, ZenQMS.).
Strong written and verbal communication skills with the ability to interpret regulations, author technical documentation, and present information effectively.
Demonstrated attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced environment.
Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry), Engineering, or related technical discipline.

Nice To Haves

Advanced degree or relevant professional certification (e.g., ASQ, PDA, ISPE) preferred.

Responsibilities

Provide day-to-day Quality oversight for GMP operations, including receipt, storage, labeling, packaging, and distribution of regulated materials.
Review and approve controlled documentation such as SOPs, work instructions, forms, and batch records.
Manage and support quality system elements including:
Deviations: Lead or support investigations, perform root cause analysis, and ensure timely implementation of corrective actions.
CAPAs: Develop, track, and verify effectiveness of corrective and preventive actions.
Complaints: Coordinate intake, investigation, trending, and resolution activities.
Change Controls: Evaluate and approve changes impacting processes, equipment, or documentation.
Ensure all activities comply with applicable regulations, internal policies, and industry standards (21 CFR Parts 210, 211, etc.).
Support inspection readiness and participate in external audits.
Partner cross-functionally with Operations, Facilities, Validation and Facilities teams to ensure consistent implementation of GMP practices.
Review and approve temperature mapping protocols, qualification reports, and other controlled documents related to cold chain operations.
Identify opportunities for process improvement and efficiency within Quality Operations workflows.
Train, mentor, and provide guidance to site personnel on GMP requirements and quality best practices.
Support the Senior Manager, Quality Operations in site quality initiatives and continuous improvement projects.