Associate Director, Project Management and Operational Excellence - Quality Assurance
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.
The purpose of the Associate Director, Quality Assurance, Project Management and Operational Excellence role is to implement formal continuous improvement methodologies within the AGT organization to improve Quality Systems; and to build a successful AGT Quality project portfolio, including establishing project governance processes, and overseeing personnel managing individual projects that impact successful licensure of Astellas Gene Therapies (AGT) products. Facilitates implementation of Quality strategies to ensure processes are harmonized with Astellas corporate processes, are simple, and are effective in delivering compliant and high quality gene therapy medicines to an increasing number of patients.
Essential Job Responsibilities:
Develops and implements strategies to formulate and successfully execute the AGT QA mission, vision and 3-5 year strategic plan. Accountable for successful execution and achievement of annual and mid term strategic goals.
Actively champions and is a role model for Quality Culture of continuous improvement, learning organization principles and innovation. Responsible for implementing formal quality improvement processes and capability within AGT.
Builds strong, collaborative relationships within and outside of quality and works effectively with partners to successfully manage complex quality projects.
Provides oversight of Projects and Project governance within Quality Assurance to ensure they stay on track and deliver intended results within predefined timelines and budget. Tracks progress of projects within the quality portfolio, proactively identifies obstacles and ensures direction, resources and focus are in place to ensure project managers are set up for success.
Demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines programs to create efficiencies in practices.
Implements and improves programs in alignment with corporate directives and best practices. Benchmarks across industry to ensure the most effective tools are in place at AGT to drive continuous improvement.
Plans, coordinates and executes individual Quality projects, initiatives and process improvements and oversees projects within the AGT QA project portfolio managed by others.
Shares best practices, provides training on relevant quality improvement tools.
Manages aspects of GMP change control as required, to implement complex systems and processes, that support quality improvement initiatives.
Developments strategies for an integrated quality approach & effective quality culture within the organization.
May act as liaison with external organizations and forums in order to bench mark and implement Quality improvement best practices to further develop the organization.
Facilitates activities that identify, align, and ensure successful completion of annual goals that support Corporate Astellas and AGT business objectives.
Performs quality due diligence activities to support evaluation and selection of new vendors and contract manufacturing organizations for AGT.
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 project management experience, including consistently creating opportunities for direct reports to improve their knowledge and skills needed in the current job; showing courage in delivering tough feedback focused on improving direct reports' performance; works with direct reports to identify and facilitate career growth opportunities.
Deep, expert level project management experience including experience leading continuous improvement projects, managing project portfolios, managing other project managers, establishing project governance processes and training others in operational excellence methodologies.
Proven Quality Assurance Operations and/or Quality Systems & Compliance experience in a cGMP biologics manufacturing environment. Experience developing strategic plans to drive organizational development and change management within a global QA organization.
Expert knowledge on quality systems/regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 600, 211), EudraLex and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization, continuously review guidance publications for industry and upcoming changes to regulations.
Deep project management and operational excellence subject matter expertise.
Demonstrated experience managing project portfolios and implementing operational excellence programs across a business unit.
Experience implementing broad organizational development changes focused around quality initiatives in the pharmaceutical industry.
Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple quality projects.
Self-motivated with ability to plan, organize and prioritize multiple tasks and able to perform under pressure to meet project deadlines having business impact.
Experience managing consultants and contractors to help drive quality improvement programs.
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.
Experience managing other project managers or personnel responsible for operational excellence initiative implementation.
Advanced computer skills with working knowledge of MS Project, Office, Word, Excel, Access, Adobe Acrobat, Minitab etc.
Exemplifies quality culture, operates with transparency and builds trusting relationships.
Project Management certification, eg PMP.
Operational Excellence, eg six sigma and LEAN green, black belt certification etc.
Experience in clinical and commercial GMP environments, including biologics and/or gene or cell therapy.
Experience with a wide variety of successful project implementations supporting clinical and commercial drug manufacturing and licensure, including manufacturing processes, facility/engineering/IT systems, Quality Assurance processes and CMC related subject matter.
Experience working with Quality systems in support of early and late-stage development programs and experience working with CMC teams.
Ability to deal with ambiguity, creative and pragmatic approach to problem solving.
Regulatory intelligence program implementation.
Experience building integrating and maintaining Quality Management Systems, QMS, with corporate systems.
Recognized auditor and quality engineering certifications.
Experience leading change efforts that bring about better results for the quality and operations teams and patients that these teams serve.
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
This is an on-site role working in an Astellas facility.
Role may require some travel to other Astellas facilities (0-10%)
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
Category Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans