Director, Vaccine Mature Products, CMC

Director, Vaccine Mature Products, CMC

Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland

Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK products. Management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles.

Key Responsibilities include, but are not limited to:

• Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives.
• Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies.
• Likely to have direct line management responsibility. Coaches and mentors staff across CMC RA on lifecycle management in CMC.
• Responsible for managing budget and resource for their teams. Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles.
• Successfully navigates internal/external networks. Leads influences and motivates staff within and across departments.
• Commercially astute and organisationally aware and able to deal with sensitive and confidential issues. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
• Delivers CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (LICs/PIRCs).
• Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company. Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence.
• Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements.
• Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines.
• Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work.
• Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.

Why you? Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Able to demonstrate the following key high-performance behaviours, customer driven, flexible thinking, and continuous improvement.
• Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
• Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
• Proven project management and multi-tasking skills.
• Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel within the company in a variety of settings.
• Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
• Experience in leading major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support.
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
• Identified as CMC Regulatory expert in a specific subject area.
• Proven experience in supervising and training staff within and across the organisation.

Closing Date for Applications: 21st January 2025 (COB)

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK.

Why GSK?
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.