Massachusetts Jobs

Quality Assurance, Site Leader (Senior Director)

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 .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Quality Assurance Site Leader (Senior Director) opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

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 overall Quality Activities at AIRM (Boston, MA area) 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

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Category BioPharma QA

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

EOE including Disability/Protected Veterans