Senior Quality Manager (Contract)

Atrium Works•Boston, MA

About The Position

The Senior Quality Manager is an advanced technical resource in quality assurance and compliance, providing end-to-end QA oversight of contract analytical laboratories supporting clinical and commercial biologics and combination product programs. The role owns vendor meetings with analytical laboratories to improve vendor performance oversight, drive timely investigation closure, and ensure alignment with Vertex quality and compliance standards. This position collaborates with internal and external partners to resolve complex quality issues, serves as a Quality resource on cross-functional teams, and supports change control, investigations, CAPA, continuous improvement, GMP documentation, risk mitigation, and audit activities. The role is a temporary assignment through a third-party agency partner, with a contract length of six months and the possibility of extension. The selected individual will be employed by the agency partner. The stated pay range is $75 to $85 per hour, with overtime eligibility in accordance with applicable requirements.

Requirements

Bachelor's degree in a scientific or allied health field, or equivalent degree.
Typically six years of experience, or an equivalent combination of education and experience.
In-depth knowledge of the conceptual and practical application of cGMPs in a pharmaceutical setting, global GMP requirements, and GMP manufacturing support.
Strong team leadership skills and ability to work in a fast-paced environment while meeting quality, accuracy, and timeliness objectives.
Ability to independently lead cross-functional teams and represent the Quality unit.
Ability to communicate complex and sensitive information to varied audiences, influence others, and gain alignment around proposed actions.
Demonstrated ability to work independently and provide QA advice for large, multifaceted projects.
Demonstrated ability to evaluate quality matters and make complex decisions using technical experience, advanced judgment, and analysis and synthesis of varied information.
Ability to work outside precedent and take a new perspective on existing solutions.
Strong experience successfully leading event investigations, root cause analysis, and CAPA.
Strong experience with electronic document management systems, such as Veeva.

Nice To Haves

Experience in early Phase to Phase 3 Analytical Quality.

Responsibilities

Collaborate with internal and external business partners to resolve complex quality issues and ensure compliant solutions.
Participate in cross-functional teams as an experienced Quality technical resource.
Draft and enforce Quality Agreements between CMOs or suppliers and Vertex, as needed.
Assist change control owners in meeting change procedure requirements; assess and approve change controls.
Conduct quality investigations and deviations, including root cause analysis and product impact assessments for deviations and out-of-specification results.
Review corrective action plans for adequacy and compliance, ensure appropriate CAPA actions are identified and addressed, and approve investigations and CAPAs.
Identify, facilitate, and/or lead continuous improvement efforts.
Maintain Quality Metrics to support process improvement activities.
Provide tactics to address compliance gaps or determine enhancements to cross-functional quality systems.
Conduct GMP document reviews, including procedures, work instructions, specifications, methods, protocols, and method reports.
Coordinate, facilitate, and follow up on assigned QLT action items.
Identify and communicate risks and assist with risk mitigation plans as necessary.
Support internal and external audit programs, manage audit CAPAs and metrics, and provide technical advice for partner and regulatory agency audits.
Own vendor meetings with analytical laboratories to strengthen performance oversight, facilitate timely investigation closure, and support alignment with Vertex quality and compliance standards.