Quality Manager

The Quality Manager provides comprehensive oversight of Quality Control (QC) testing activities and contract testing laboratories, ensuring robust analytical methods, compliant product release, and alignment with global regulatory expectations. This role leads the governance of QC documentation, stability programs, and quality systems, while partnering closely with internal teams and external CDMOs and CTLs to maintain high standards of product quality and patient-focused outcomes.

Responsibilities

• Provide end-to-end oversight of contract testing laboratories (CTLs) and QC testing activities, ensuring all work complies with applicable GxP and GMP requirements.
• Oversee the development, review, and approval of Justification of Specifications (JOS), product specifications, and Certificates of Analysis (CoA) to support compliant product release.
• Ensure comprehensive lifecycle management and validation of analytical methods at CTLs, including proper implementation, maintenance, and change control.
• Lead oversight of stability and shelf-life programs, monitoring expiry dating and stability trends to maintain product quality throughout the product lifecycle.
• Perform QA review of QC test data and contribute to batch disposition decisions for starting materials, drug substance, and drug product in collaboration with cross-functional teams.
• Coordinate batch disposition activities across internal groups and external partners to ensure timely and compliant product release.
• Lead and support investigations and resolution of QC quality events, including deviations, Change Control Records (CCR), and Corrective and Preventive Actions (CAPA) across internal departments, CDMOs, and CTLs.
• Manage QC documentation and quality processes for both internal and external partners, including oversight and maintenance of Quality Technical Agreements with CTLs.
• Define, implement, and maintain the CTL oversight model, including risk-based oversight strategies, monitoring of key performance indicators, and clear escalation pathways.
• Support the implementation of EU in-country testing strategies in collaboration with relevant stakeholders and external partners.
• Provide quality input and documentation support for regulatory filings, ensuring compliance with global standards and facilitating successful submissions.
• Participate in internal and external cross-functional meetings, providing quality guidance, risk mitigation support, and recommendations for path-forward decisions.
• Contribute to continuous improvement initiatives within the Quality Assurance department and across other functions, identifying opportunities to enhance quality systems, processes, and efficiency.
• Utilize and help optimize electronic quality management systems and other digital tools, such as ZenQMS, Veeva, and Trackwise, to manage deviations, CAPAs, change controls, and batch record reviews.
• Support technology transfer, process validation, and analytical method development activities from a QA/QC perspective, ensuring appropriate quality oversight.
• Perform batch record review and ensure all quality documentation is complete, accurate, and audit-ready.
• Carry out additional quality-related duties as assigned based on evolving company and departmental needs.

• Minimum of 8 years of experience in a quality assurance department within the biotech or pharmaceutical industry.
• Strong, hands-on experience in GxP QC and analytical roles in addition to QA responsibilities.
• Deep understanding of GMP requirements as they relate to QC and analytical testing.
• Proven experience working with contract testing laboratories (CTLs) and CDMOs.
• Demonstrated expertise in Quality Control and QC analytical activities, including analytical method development and validation.
• Practical experience with batch record review, QA review of test data, and batch disposition for starting materials, drug substance, and drug product.
• Strong knowledge of quality systems and electronic quality management systems, with direct experience using at least one eQMS platform.
• Experience managing deviations, CAPAs, change controls, and other quality events within a structured QMS environment.
• Working knowledge of GxP and GMP regulations and their application to drug product manufacturing and testing.
• Ability to lead and support investigations, identify root causes, and implement effective corrective and preventive actions.
• Strong analytical, documentation, and organizational skills, with careful attention to detail in reviewing technical and quality records.
• Effective communication and collaboration skills to work with internal stakeholders and external partners, including CTLs and CDMOs.

• Preference for direct experience with ZenQMS as an electronic quality management system.
• Experience with other quality systems such as Veeva and Trackwise.
• Experience with Laboratory Information Management System (LIMS) implementation or use.
• Experience in QA for QC analytical operations, including oversight of analytical QC activities.
• Experience with technology transfer and process validation in a drug product environment.
• Familiarity with developing EU in-country testing strategies and related regulatory considerations.
• Experience working within GxP environments across the product lifecycle, including drug product manufacturing and testing.
• Ability to define and apply risk-based oversight strategies and monitor key performance indicators for CTLs and external partners.
• Comfort working in a patient-focused, mission-driven organization that aims to be a center of excellence in its disease area.
• Continuous improvement mindset, with the ability to identify and implement enhancements to quality systems and processes.

This position operates in a primarily remote work environment, offering flexibility to work from home while collaborating with global internal teams and external partners. Candidates located near a company site may choose to work onsite if they prefer. The role follows a Monday through Friday, first-shift schedule and supports cross-functional collaboration across Quality Assurance, Quality Control, and external CDMOs and CTLs. Work is highly digital and system-driven, leveraging electronic quality management systems such as ZenQMS, Veeva, and Trackwise, as well as other laboratory and quality tools. The organization emphasizes a patient-focused, mission-driven culture, scientific excellence, and cross-functional teamwork, with a strong commitment to improving the daily lives of individuals living with serious diseases.

Job Type & Location

This is a Contract position based out of Boston, MA.

The pay range for this position is $60.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Boston,MA.

This position is anticipated to close on Jun 23, 2026.