Head, Global Process & Standards Excellence - United Kingdom - ref. g16444219
Head, Global Process & Standards Excellence
About Astellas
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing 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 caregivers, 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.
The Opportunity
As the Head of Global Process & Standards Excellence, you will ensure operational excellence by developing, executing, and overseeing business change initiatives. You will bring industry insights to influence Medical Affairs (MA) strategies and activities across Astellas, driving the establishment of standards for MA activities to ensure global consistency and compliance.
Your role will involve managing risk and promoting process efficiency through the direction, oversight, and evaluation of processes owned by MA senior leaders. You will collaborate with leaders in MA Operations, Regional MA Operations, Country MA Operations, Core Medical Teams (CMT), Ethics & Compliance, Legal, and Development to implement change initiatives and maintain MA standards.
This role reports to the Executive Director, Medical Affairs Operations.
Responsibilities:
- Demonstrating a strong understanding of global Medical Affairs standards, processes, and procedures, ensuring cross-functional connections and operational processes are appropriately and effectively developed and communicated across the organization.
- Establishing cross-functional standards in alignment with regulations, codes, and industry standards, especially impacting and influencing multiple departments and levels of management.
- Bringing extensive experience in people management, with significant exposure to leading matrix teams. Will take accountability for the direct oversight and management of a team. Leading with a demonstrated ability to influence and gain alignment in cross-functional, multiregional, and matrix teams.
- Collaborating with functional Operational Excellence leads and closely partner with Process Owners for various activities that drive establishment and maintenance of MA standards (e.g. Medical Information; Project Management; TA Leads) and other functions (PV, Development, etc.).
- Partnering with various members of the Medical Affairs Leadership team, to define or execute agreed strategic direction for procedures and risk management.
- Extensive experience within the pharmaceutical industry including within Medical Affairs regulated/code driven environment, or in drug development under GxP.
- Qualified in Change Management or significant experience in successfully implementing and embedding organization-wide process changes.
- Solid project management experience, preferable in a highly matrixed, multicultural global setting.
- Demonstrable ability to see and communicate a vision, formulate an associated strategy, and align tactics to that strategy, for successful execution of the vision.
- Experienced in translating solutions into viable action plans that are effectively disseminated and implemented through cooperation of stakeholders, on a global scale.
- Bachelor’s Degree or equivalent.
- Advanced degree such as MBA, PhD or MD
- Six Sigma, Kaizen or comparable process improvement methodology certification
- Prosci or comparable change management certification
- This is a permanent full-time position.
- May require up to 15% international travel.
- Primarily based in the UK or EU4 major markets.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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.