Director, PV Quality Management in High Wycombe

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Johnson & Johnson is recruiting for a Director, PV Quality Management located in multiple locations including High Wycombe, UK, and Maidenhead, UK.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Innovative Medicine Quality Systems (IMQS) is responsible for the Innovative Medicine Quality Management Systems (QMS) and GxP Process Ownership, and is the Global Process Owner for Quality Management Processes. IMQS ensures foundational governance through quality performance management, and alignment with regulatory requirements and emerging industry expectations.

The IMQS-Process and Data Management (PDM) team specifically focuses on and partners with R&D and Pharmacovigilance and collaborates with key partners including R&D Quality, Johnson & Johnson Enterprise Innovation (JJEI), the Therapeutic Areas (TA), Global Development (GD), Global Regulatory Affairs (GRA), and the Global Medical Organization (OCMO/GMS) along the development process, from discovery, pre-clinical, clinical, launch to post-approval activities.

As Director, Pharmacovigilance Quality Management, you lead a global team of PV Quality Management experts overseeing the end-to-end delivery of process, qualification and training in the IMQS supported QMS framework. You enable dedicated Business Partners to conduct R&D/Medical Safety in an efficient and compliant way, resulting in programs that allow for seamless registration of the J&J innovative products.

You set the vision and strategy for process and personnel qualification management in collaboration with senior leaders in R&D functions. You are the single point of contact for senior management with business partners where you are responsible for roll out and training of the overall applicable quality framework.

As an owner of the E2E procedural framework, you are responsible for overall development of the PVQM strategy and ensuring Quality-by-Design principles are instigated in all PVQM deliverables. You play a strategic and operational role in coordinating the work of the PPQM team in a respective business unit.

Tasks/Duties/Responsibilities:

• Map, analyze, develop, and implement compliant and efficient end-to-end processes and related training and qualification as part of the GxP/GPvP Quality Management Framework.
• Represent IMQS-PDM and serve as a champion to key (pre)clinical, OCMO and Global/Local Medical Safety, Therapeutic Area and other business partners and stakeholders.
• Implementation of the transformation roadmap of PDM towards data-centric content and qualification management.
• Lead and manage a team of PVQM Experts.

Required Minimum Education: Master’s degree in Science or Business.

Required Years of Related Experience: A minimum of 12 years’ experience in a medium to large scale matrix organization, including a minimum of 10 years of experience in a pharmaceutical/device compliance-related field and/or equivalent time and experience in a related healthcare R&D area is required. A minimum of 5 years’ experience in the field of Medical Safety/Pharmacovigilance, process design, training design or related field is required.

Required Knowledge, Skills and Abilities:

• The ability to communicate well, both in oral and written form (in English) and using a variety of media.
• Demonstrated competencies include industriousness, self-awareness, adaptability, attention to detail and a high capacity for teamwork.
• Strong knowledge of worldwide (pre)clinical safety compliance regulations and guidelines.

Leadership experience and skills:

• Strong personal leadership with demonstrated competency interfacing with senior leaders.
• Strong networking and relationship-building skills.
• A proven track record of leading and developing people in a matrixed organizational set-up.

Technology experience and skills:

• Proficiency with MS365 software.
• Proficiency with Project Management software.