Senior Manager, Quality Systems

Senior Manager, Quality Systems

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed. 

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. 

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. 

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. 

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. 

About this job:

The Senior ManagerQuality Systems assumes a pivotal role within Astellas, ensuring strict adherence to global GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) standards across all facets of the organization's clinical and commercial product portfolio. In this integral position, the manager serves as the guardian of quality, meticulously overseeing the implementation of Astellas' Supplier Evaluation Program to safeguard product integrity and patient safety.

As a trusted steward of Astellas' quality assurance initiatives, the incumbent conducts and leads a spectrum of cGMP audits, meticulously scrutinizing external suppliers and Contract Manufacturing Organizations (CMOs) to evaluate risks and mitigate compliance discrepancies. Beyond mere oversight, the manager embodies Astellas' commitment to excellence by representing the organization in external audits, where comprehensive knowledge of global GMP and GDP requirements serves as the bedrock for setting rigorous quality expectations.

With an unwavering dedication to upholding the highest standards, the Senior ManagerQuality Systems assumes a multifaceted role, balancing the complexities of regulatory compliance with the imperatives of operational efficiency. By cultivating a culture of compliance and continuous improvement, the manager ensures that Astellas remains at the vanguard of pharmaceutical excellence, driving innovation while safeguarding patient welfare.

Hybrid working:

At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

In this role, you will:

• Conduct and lead meticulous cGMP audits of external suppliers and CMOs, as well as internal audits of Astellas entities, ensuring comprehensive evaluation and adherence to stringent quality standards.
• Collaborate closely with cross-functional teams to prepare formal reports, update databases, and implement corrective actions, thereby fortifying Astellas' compliance with corporate policies and regulatory mandates.
• Harness your expertise in GMP and GDP regulations to identify and address major compliance issues, steering the organization towards best practices and sustainable quality improvement.
• Provide visionary leadership, driving a culture of ethics and compliance while fostering collaboration and engagement across diverse stakeholders, both internally and externally.
• Act as a beacon of integrity and professionalism, representing Astellas with distinction during regulatory inspections and external audits, thereby reinforcing the organization's commitment to quality excellence.

Essential Knowledge & Experience:

• Extensive experience in the pharmaceutical sector, underpinned by a steadfast dedication to customer-centricity and quality assurance.
• Proven track record of orchestrating and leading Quality Audit processes, coupled with a deep-seated understanding of compliance principles and regulatory frameworks.
• Outstanding interpersonal skills, enabling effective collaboration and communication with stakeholders at all levels of the organization.
• Academic background in the sciences or equivalent professional qualifications, complemented by specialized expertise in GMP, GDP, and quality assurance standards.
• Certification in auditing of Pharmaceutical Quality systems (PQS) or equivalent preferred, attesting to a mastery of audit methodologies and best practices.

Preferred Knowledge & Experience:

• Ability to facilitate seamless communication and collaboration across diverse global teams.
• Thorough comprehension of global GMP and GDP requirements, augmented by experience in regulatory intelligence monitoring and reporting.
• Demonstrated leadership acumen and strategic planning abilities, instrumental in driving continuous improvement and operational excellence.
• Proven ability to influence and engage diverse stakeholders in a matrix organization, fostering a culture of compliance and accountability.
• Prior experience in authoring, revising, and administering controlled documents, showcasing meticulous attention to detail and compliance integrity.

Additional information

• This is a permanent, full-time position.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 days per week in our Leiden office. Flexibility may be required in line with business needs. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
• Global Travel: Ability to travel extensively in the EMEA region, occasionally to Asia or America, usually for periods of 1-3 days.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.