Senior Director, Quality Assurance, Commercial

About the Role

We are seeking a Senior Director, Quality Assurance, Commercial as an integral leader within the Quality GMP team and a key member of the highly collaborative R&D Operations group, which includes Program Management, CMC, Regulatory Affairs, Supply Chain, and Quality functions. This role ensures Quality program requirements are met across all manufacturing stages (Drug Substance, Drug Product, Finished Goods) of products for commercial distribution. The successful candidate will have proven leadership ability in a fast-paced and complex environment, interacting with all levels of internal staff, external advisors, and partners. This position reports to the Executive Director, Quality Assurance, GMP and will be based in our Needham, MA office (Boston area), with hybrid work requiring a minimum of 2 days per week in the office. Other jurisdictions may be considered for exceptional candidates.

Responsibilities

• Lead and manage key activities related to commercial manufacturing, testing, and disposition of product at CMOs in accordance with regulatory and internal requirements, including batch reviews and release, tech transfers and validations, deviations, quality agreements, and supplier qualifications (including auditing and monitoring).
• Effectively lead and manage a global team to ensure functional and program objectives are met.
• Collaborate with leaders within the CMC and Supply Chain organizations to ensure key objectives for commercial programs and small molecule products, ensuring cGMP compliance and implementing value-added policies and best practices.
• Recommend and implement strategic system improvements for commercial Quality requirements such as CPV, APR, and KPI metrics.
• Attend CMO and internal CMC team meetings; provide feedback and collaborate on complex investigations. Escalate or advise on key topics as required.
• Support the Quality Systems team and contribute to product review meetings; present Quality metrics (internal and vendor metrics).
• Provide timely reports and reviews of key CMC and health authority documents.
• Represent the Quality function as a trusted advisor on product development teams (PDTs), Health Authority Inspections, for suppliers, and at CMO operational meetings, including “QA to QA” meetings.
• Promote a Quality and patient-first mindset and inspire Quality excellence throughout the organization.
• Recruit, lead, direct, develop, coach, and evaluate direct reports in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including the Code of Business Conduct and Ethics, and ensure policies are understood and followed by direct reports.
• Some international travel may be required.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a life sciences discipline, with 12+ years of relevant management experience in GMP quality leadership positions; an advanced degree is preferred.
• Strong understanding of small molecule manufacturing, including drug substance manufacture, drug product manufacture with direct experience in solid oral dosage, and finished goods production and distribution.
• Experience with virtual manufacturing partners (CMOs).
• Extensive GxP knowledge with commercial production/disposition experience.
• Strong knowledge of global GxP expectations and QP (Qualified Person) requirements.
• Ability to effectively organize, multitask, and work in a fast-paced, deadline-driven environment.
• Extensive experience establishing key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
• Strong interpersonal skills, with experience leading cross-functional projects and a successful track record working with suppliers and CMOs.
• Ability to communicate proactively and solution-focused, including keeping management aware of potential issues and addressing CMO-related concerns.
• Goal-oriented with the ability to troubleshoot and resolve problems.
• Champion for continuous improvement in all aspects of total quality management.
• Ability to work independently to set priorities and meet timelines.
• Previous experience leading and managing on-site and remote employees.

Benefits

• Base salary, target bonus, and stock options.
• Medical, dental, vision, short- and long-term disability, accidental death & dismemberment, and life insurance programs.
• Employee Assistance Program and travel insurance.
• Retirement savings programs with company matching contributions.
• Paid time off, including vacation, personal days, sick days, and an end-of-year company shutdown.
• Employee development programs, including a Tuition Assistance program for advanced degrees.

Pay

Compensation Range: $258,000 - $281,700.

Schedule

Hybrid position requiring a minimum of 2 days per week in the office.