Job Description
Johnson & Johnson is recruiting for a Director, PV Quality Management (Pharmacovigilance Quality Management) across multiple locations: Titusville, NJ; Raritan, NJ; Beerse, Belgium; High Wycombe, UK; Maidenhead, UK; Allschwil, Switzerland; Schaffhausen, Switzerland.
Responsibilities
* Map, analyze, develop, and implement compliant and efficient end‑to‑end processes and related training and qualification as part of GxP/GPvP Quality Management Framework.
* Represent IMQS‑PDM and serve as a champion to key (pre)clinical, OCMO, Global/Local Medical Safety, Therapeutic Area, and other business partners and stakeholders.
* Ensure the GxP/GPvP Quality Framework evolves with the business and regulatory requirements and needs, including changes, CAPA, investigational/inspectional requests.
* Implement the transformation roadmap of PDM towards data‑centric content and qualification management, and the internal first‑time‑right end‑to‑end process from request to effective process/qualification material.
* Lead and manage a team of PVQM experts.
* Support leadership or other projects, meetings, etc. as directed by the Head of Process and Data Management.
* Act independently to drive results and organizational performance, setting priorities to achieve IMQS goals and objectives.
Additional Responsibilities
* Leadership or support of projects, meetings, etc. as directed by the Head of Process and Data Management.
* Act independently to drive results and organizational performance.
* Lead and be proactive in setting priorities to achieve IMQS goals and objectives.
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.
* Minimum of 5 years’ experience in Medical Safety/Pharmacovigilance, process design, training design or related field.
Required Knowledge, Skills and Abilities
* Strong communication skills in oral and written English.
* Industriousness, self‑awareness, adaptability, attention to detail and teamwork.
* Strong knowledge of world‑wide (pre)clinical safety compliance regulations and guidelines, and broad exposure to regulatory and legal requirements within the life science industry.
* Ability to resolve complex problems within tight timelines.
* Decision‑making skills regarding business issues, strategic support, and organizational development.
Leadership Experience and Skills
* Strong personal leadership with demonstrated competency interfacing with senior leaders.
* Strong networking and relationship‑building skills.
* Proven track record of leading and developing people in a matrixed organizational set‑up.
* Strong organizational and people change leadership and management skills.
* Ability to create an open and inviting environment and embrace generational differences.
* Ability to operate in a virtual environment.
* Proven business acumen.
* Strong understanding of digital and data science landscape.
* Exceptional written and verbal communication skills.
Technology Experience and Skills
* Proficiency with MS365 software.
* Proficiency with Project Management software.
* Proficiency with Process Value Stream mapping and analyzing software (preferred).
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