Manager of Quality Operations

About Tobin Scientific

Tobin Scientific is a leading provider of cold chain ambient storage and transport & logistics services for the biopharma industry. We proudly support a diverse clientele spanning life sciences academia government and more. Recognized for unwavering safety and reliability in the storage and transport of temperature-sensitive products we excel in serving the complex needs of the pharmaceutical and biotech sectors. Our capabilities extend to laboratory relocation principal investigator support and other logistic services. Tobin Scientifics all-encompassing approach and commitment to quality make us an industry innovator empowering our partners through the complexities of the biopharma industry.

Position Summary

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.

Key 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.

Education

• Bachelors degree in Life Sciences (e.g. Biology Chemistry Biochemistry) Engineering or related technical discipline.
• Advanced degree or relevant professional certification (e.g. ASQ PDA ISPE) preferred.

Experience and Qualifications

• 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 (-20C 2-8C and 15-30C).
• 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.

Benefits:

• Health
• Vision
• Dental
• Life Insurance: Basic and Supplemental
• Long Term Disability
• 401(K) Match
• Unlimited Vacation
• Weekly Pay
• Referral Program
• 9 Paid Holidays
• Tuition Reimbursement

Pay Range:
The annual salary range for this position is as follows:

$100000 - $120000.

Compensation depends on relevant experience and/or education specific skills function geographic location and other factors as applicable by law.

Tobin Scientific is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status. We are committed to creating an inclusive environment for all our employees.

Required Experience:

Manager