Quality Assurance Site Leader (Senior Director)

Astellas Pharma - Westborough, MA

Full-time - Senior

Westborough, MA

Management of Companies and Enterprises

About the position

The Quality Assurance Site Leader (Senior Director) at Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA, plays a pivotal role in ensuring the quality and compliance of pharmaceutical products. This position is designed for a strategic leader who will oversee all aspects of Good Manufacturing Practice (GMP) and non-GMP Quality Assurance (QA) activities. The Site Leader will collaborate closely with the site management team and will be responsible for supervising a team of QA managers and specialists. The primary goal is to ensure that all operations comply with regulatory requirements, Astellas Quality standards, and local site policies and procedures. In this role, the Site Leader will develop and implement quality strategies that align with both short- and long-term objectives for the QA organization. This includes ensuring compliance with established standard operating procedures (SOPs) and preparing for regulatory authority inspections. The Site Leader will also foster a culture of quality and compliance within the organization, encouraging independent thinking and strong relationships across various functions. The position requires a proactive approach to quality improvements, with responsibilities that include evaluating trends and risks, optimizing QA processes, and acting as the primary interface with Regulatory Authorities. The Site Leader will also be involved in mentoring and developing QA professionals, ensuring that the team is equipped to meet the challenges of the pharmaceutical industry. This role is critical in maintaining the integrity of Astellas' commitment to delivering innovative therapies to patients.

Responsibilities

• Provide strategic leadership and QA oversight for all GMP and non-GMP activities.
• Supervise a team of QA managers and specialists to ensure compliance with regulatory requirements and Astellas Quality standards.
• Develop quality strategies and priorities for the QA organization to fulfill regulatory requirements for GMP and compliance for CTM and commercial products.
• Ensure alignment with Global Quality Assurance requirements and prepare for regulatory authority inspections.
• Collaborate with Global BioPharma Mfg. Division management to meet stakeholder needs.
• Foster a culture of independent thinking and strong relationships across multiple functions.
• Mentor and support direct reports and assess ongoing resource needs.
• Evaluate trends and risks to optimize site Quality Assurance processes.
• Act as the primary interface with Regulatory Authorities and support regulatory inspections and internal audits.

Requirements

• BA/BS degree required, preferably in a life science discipline, with 10+ years of relevant experience; Advanced degree with 6+ years related experience.
• Comprehensive knowledge of GxP and other regulations, and understanding of global quality standards relating to product development and commercialization.
• Effective leadership and influencing skills with a demonstrated ability to build collaborative relationships across multiple departments and external stakeholders.
• Demonstrated ability to assess current business and QA operations to identify and recommend improvements.
• Competence in resolving complex problems with significant decision-making responsibility.
• Experience in developing quality strategies and translating them into objectives for the department.
• Ability to develop quality assurance professionals and manage a functional quality assurance unit.
• Strategic thinking and ability to influence without authority in a matrix environment.
• Strong time-management, prioritization, and analysis skills.

Nice-to-haves

• Advanced degree (MS, MBA)
• 10+ years of leadership experience

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program