Senior Manager, QA Compliance

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence 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 their 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.astellasgenetherapies.com .

This position is located onsite at the Sanford, NC location.

The Role

The primary purpose of the Senior Manager, Quality Assurance, Compliance is to provide Quality and Compliance oversight to Astellas Gene Therapies (AGT). The role is responsible for implementation and oversight of the AGT Supplier Management program, internal audit program, inspection management and compliance oversight required to support GMP manufacturing operations at AGT GMP operations as well as GMP suppliers. This role will be responsible for maintenance of supplier qualification program, negotiation of quality agreements and ensuring compliance with internal and external audit schedules.

Responsibilities

Implements and improves programs in alignment with corporate directives and best practices.

Ensures that quality agreements are negotiated, approved, and assessed periodically.

Manages Astellas Gene Therapies’ supplier qualification program: Maintains approved supplier list (ASL), ensure that supplier qualification is maintained, ensure compliance to supplier audit schedule, establish and manage supplier quality metrics and report outs to stakeholders.

Manages supplier qualification and lifecycle management activities, including initial qualification, requalification and disqualification.

Ensures supplier management activities including audits, quality agreements and SCAR programs are operated within compliance and within performance metrics.

Ensures metrics are routinely tracked and reports in departmental and site management review.

Conducts quality audits at suppliers and contract manufacturers, report results to project team personnel and management, and interact with teams to ensure corrective actions are implemented.

Designs and actively participates in special assignments on various project teams and work streams as determined by QA management.

Directs internal audit program, including ensuring annual schedule is approved, audits are executed, and corrective actions are implemented to improve compliance.

Establishes and leads inspection readiness program to ensure successful licensure of new gene therapy products and act as host for corporate, QP and health authority inspections.

Maintain compliance related documents including Site Master File (SMF) and Annual Product Quality Review (APQR) for commercial products.

Lead regulatory inspections and corporate auditing related projects.

Performs other duties as assigned or special projects as needed.

Required Qualifications

Bachelor’s degree in a scientific or technical discipline, and 10 years of pharmaceutical experience in biotechnology or pharmaceutical industry in quality or quality systems in people or team leadership roles, 8 years of experience with MS and 6 years of experience with PhD, or equivalent combination of education and experience.

4 years related management experience (people/processes or systems), including consistently creating opportunities for colleagues to improve their knowledge and skills needed in their current job; showing courage in delivering tough feedback focused on improving colleague performance; works with direct reports to identify and facilitate career growth opportunities.

Expert level knowledge of regulatory requirements (US and International) related to GMP manufacturing and testing of drug product, including data integrity, quality control testing standards, quality systems, drug development and commercial production.

Leads change efforts that bring about better results for the team; team members are early adopters for new solutions and procedures within the function.

Proven QA experience including successful implementation and oversight of Quality Management Systems, inspection readiness and health authority inspection management in a cGMP biologics manufacturing environment.

Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.

Regularly interacts with senior management or executive levels on matters concerning

several functional areas. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.

Strong analytical, communication, and negotiation skills as well as sound judgment, with the ability to work effectively with others.

Advanced computer skills with working knowledge of MS office, Word, Excel, Access, Adobe Acrobat, etc.

Preferred Qualifications

Master’s degree or higher education preferred.

ASQ Auditor Certification or equivalent experience

Experience in clinical and commercial GMP environments.

Experience working with Quality systems in support of early, late-stage development, and commercial programs.

Experience with quality management tools, e.g. Veeva, TrackWise.

Self-motivated with ability to plan, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines.

Experience working with external partners and management of suppliers.

Ability to deal with ambiguity, creative and pragmatic approach to problem solving.

Developing and implementing compliance related metrics for Quality Management Review and site compliance tracking.

Flexible grade level based on candidate background and skillset

Working environment:

This position is an on-site role working in a cGMP regulated manufacturing facility based in Sanford, NC and will require on-site work.

Benefits:

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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Category BioPharma QA

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

EOE including Disability/Protected Veterans