Quality Assurance, Site Leader (Senior Director)

Quality Assurance, Site Leader (Senior Director)

Are you ready to use your experience and expertise to make an impact on patients’ lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you’d like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellas.com .

Our Values:

Be BOLD (Find a Way)

Care Deeply – for our patients, each other and our work

#GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

Astellas is announcing a Quality Assurance Site Leader (Senior Director) opportunity at their Astellas Gene Therapy (AGT) site in Sanford, NC.

Purpose:

The primary purpose of the Quality Assurance Site Leader is to provide strategic leadership, QA oversight and partner with site management team and is accountable for the execution of all aspects of GMP or non-GMP QA activities. This position will supervise a team of QA managers/specialists and oversee a wide variety of activities to ensure compliance with applicable regulatory requirements, Astellas Quality standards, and local site policies and procedures. The local Quality Assurance department is responsible for developing, reviewing, and approving Standard Operating Procedures, Batch Records, Process Support Documentation & Training Materials. This position will have opportunities to integrate compliance initiatives cross-functionally, provide ownership for internal processes and identify areas for quality improvements.

Essential Job Responsibilities:

Develops quality strategies and priorities for short- and long- term objectives for the QA organization to fulfill the regulatory requirements for GMP and compliance for CTM and commercial products.

Ensures alignment with Global Quality Assurance requirements and other functional areas to ensure processes comply with established standard operating procedures (SOPs) and regulatory requirements including regulatory authority inspection preparation for internal facilities and key contract manufacturers.

Collaborates with Global BioPharma Mfg. Division (T&M) management and provides QA site leadership to ensure stakeholder’s needs are met.

Provides oversight and leadership to the Quality Organization to foster a culture that encourages independent thinking and personnel who excel at building strong relationships across multiple functions, both locally and globally.

Provides leadership, development, mentoring and support for direct reports and their staff as well as ongoing resource assessment. Enables the selection of contract manufacturing and contract laboratory organizations to facilitate process improvement and scale-up activities, as needed.

Ensures alignment of processes associated with quality assessment of contract manufacturer to proactively influence CMO manufacturing site selection, supplier qualification / maintenance and technology transfer activities and/or within greater Astellas where applicable.

Evaluates trends and risks and drive the optimization of the site Quality Assurance processes and organization accordingly.

Demonstrates effective communication and escalates Quality issues to senior management as needed.

Acts as the primary interface with Regulatory Authorities on behalf of site and supports regulatory inspections and internal audits, as needed.

Performs other duties as assigned or special projects as needed.

Qualifications Required:

BA/BS degree required (degree emphasis in life science discipline preferred), with 10 years 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, submission and/or commercialization.

Effective leadership and influencing skills with a demonstrated ability to build collaborative relationships across multiple departments, regions and business units and external stakeholders.

Demonstrated ability to assess the state of current business and QA operations for Quality Assurance to identify and recommend future state and drive improvements.

Demonstrated competence to resolve complex and diverse problems with decision-making responsibility that has a major impact (e.g., stakeholder relationships, dossier approvals, compliance status, credibility and/or revenue) within QA and within the region.

Demonstrated experience developing quality strategies and priorities and translating them into short and long-term objectives for the department.

Demonstrated ability to develop quality assurance professionals and to both lead and manage a functional quality assurance unit.

Ability to foster and balance a culture of compliance within a culture of innovation.

Strategic thinking; ability to influence without authority, in a matrix environment.

Exerts influence in the development of overall objectives and long-range goals of the organization.

Strong time-management, prioritization and analysis skills and sense of urgency.

Collaborative team player – communicates well with team members and stakeholders across Astellas, thinks the best for the team, act quickly, identify creative solutions to complex problems, respect others, embrace diversity and be accountable.

Proficient knowledge of MS Word, Excel, PowerPoint, Outlook and Teams.

Preferred:

Advanced degree (MS, MBA)

10 years of leadership experience

Working Environment:

This position is based in the United States and will require primarily on-site work to provide oversight of the AGT Sanford (Sanford, NC), as required.

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

#LI-LK

Category BioPharma QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans