Senior Manager Quality Operations

The Sr. Manager, Quality Operations will report to the Senior Director Global Quality Assurance and be responsible for global GMP quality within our internal and external manufacturing operations for development and commercial programs. This position will lead the Quality Operations team who provide daily operational quality support. This is an in-person role based at our Northbridge facility. We offer a hybrid work schedule.

The expectation will be at least three days in the office but could be more at times as we approach upcoming critical milestones.

• Builds, develops and leads the site quality operations team from process validation (PPQ) into commercial drug product manufacturing.
• Manage activities related to incoming material release, batch record review, QC testing, lot disposition, Quality Event Management, Annual Product Report reconciliation, and quality oversight at our Northbridge location.
• Collaborate with Quality and Manufacturing Leadership to gain insight into organizational goals, priorities, and requirements.
• Develop and communicate goals and priorities for the team that correlate to and support the organizational and corporate goals.
• Implement and maintain quality systems, policies and procedures that ensure compliance to cGMP, FDA (i.e. 21
  
  CFR
  11, 820, 210, 211) and other regulatory standards.
• Oversight and performance of manufacturing batch production record review and approval in support of product release/disposition in accordance with specifications and procedures.
• Oversight and performance of test record data review and approval in support of stability testing and laboratory testing in accordance with specifications and procedures.
• Supports and assists with Quality Systems-related training, including compliance with cGMP and SOPs.
• Interfaces with quality, CMC, manufacturing, and supply chain personnel from external parties (e.g., CMOs or CTOs).
• Provides QA review/approval of cGMP documents generated across the organization which includes, but is not limited to: SOPs, technical reports, validation documents, risk assessments, manufacturing records, APQRs, audit documents, change control, deviation & CAPAs.
• Participates in mock and regulatory inspections.
• Actively engages in the training of staff with lesser experience or knowledge of quality operations processes. Educates and instructs QA and plant personnel in quality best practices for sampling, labeling, good documentation practices, equipment sanitation. Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed.
• Routinely provides input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
• Participate in a range of on-going projects and team initiatives.
• Serve as the Quality Lead on product development teams in collaboration with Quality Engineering.
• Expert knowledge and experience in leading teams in root cause analysis determination.
• Other duties as assigned.

• This position has direct supervisory responsibilities of the Northbridge Site Quality Assurance Operations team.
• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources.
• Ability to delegate or review, approve and critique protocols and reports of equipment and pharmaceutical combination products.
• Experience with inspection readiness initiatives and in involvement with PAI inspections.
• Demonstrated strong GMP experience with an understanding of all aspects of technical development and manufacturing from product development through commercialization, including validation.
• Strong background and demonstrated effectiveness in managing Quality Assurance Operations and compliance of commercial combination products in an FDA regulated environment.
• Experience with implementing and managing Quality On The Floor process.
• Knowledge of electronic manufacturing support systems including ERP and MES highly desirable.
• Strong analytical, problem solving, and decision-making skills.
• Self-reliant in meeting goals and objectives.
• Flexible and able to respond quickly to shifting priorities and meet deadlines.
• Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment.

• Experience auditing or holds auditor certification.
• Experience in overseeing CMO operations.
• Combination device experience.
• Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development.

• Bachelor’s degree required (Scientific discipline, or other technical disciplines); master’s degree a plus.

• Minimum of 10+ years of related experience in the pharmaceutical or biotechnology industry, preferably in pharmaceutical development and…