Quality Assurance, Site Leader (Senior Director)

Astellas Pharma - Sanford, NC

Full-time - Senior

Sanford, NC

Management of Companies and Enterprises

About the position

The Quality Assurance Site Leader (Senior Director) at Astellas Gene Therapies is responsible for providing strategic leadership and oversight for all aspects of Quality Assurance (QA) activities at the Sanford, NC site. This role involves ensuring compliance with regulatory requirements and Astellas Quality standards, supervising a team of QA managers and specialists, and integrating compliance initiatives across functions. The position plays a critical role in developing quality strategies, fostering a culture of compliance and innovation, and acting as the primary interface with regulatory authorities.

Responsibilities

• Develop quality strategies and priorities for short- and long-term objectives for the QA organization.
• Ensure alignment with Global Quality Assurance requirements and other functional areas.
• Collaborate with Global BioPharma Mfg. Division management to meet stakeholder needs.
• Provide oversight and leadership to foster a culture of independent thinking and strong relationships across functions.
• Mentor and support direct reports and assess ongoing resource needs.
• Ensure alignment of processes associated with quality assessment of contract manufacturers.
• Evaluate trends and risks to optimize site Quality Assurance processes.
• Communicate effectively and escalate Quality issues to senior management as needed.
• Act as the primary interface with Regulatory Authorities and support regulatory inspections.

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 global quality standards.
• Effective leadership and influencing skills with a demonstrated ability to build collaborative relationships.
• Ability to assess current business and QA operations and recommend improvements.
• Competence to resolve complex problems with significant impact within QA.
• Experience developing quality strategies and translating them into objectives.
• Ability to develop quality assurance professionals and manage a functional unit.
• Strategic thinking and ability to influence 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