Director, PV Quality Management
Johnson & Johnson is recruiting for a Director, PV Quality Management located in Titusville, NJ, Raritan, NJ, Beerse, Belgium, High Wycombe, UK, Maidenhead, UK, Allschwil, Switzerland or Schaffhausen, Switzerland.
Overview
The Independent Medicines Quality Systems (IMQS) organization is responsible for the Innovative Medicine Quality Management Systems (QMS) and GxP process ownership. The Director, Pharmacovigilance Quality Management leads a global team of PV Quality Management experts to deliver end‑to‑end processes, qualifications and training within the IMQS‑supported QMS framework. The role ensures compliance with regulatory requirements, drives quality‑by‑design principles, and collaborates with senior leaders across R&D, Medical Safety, and global business partners.
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.
* Act as conduit between business partners, quality groups and governance to ensure the GxP/GPvP Quality Framework evolves with the business and regulatory requirements and needs, including changes, CAPA, investigational/inspection requests.
* Implementation of 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.
* Coordinate the work of the PPQM team in a respective business unit and collaborate with business partners managing the delivery of end‑to‑end connected processes.
* Develop functional programs for PVQM staff and identify developmental needs, preparing personnel for more responsible positions and increasing effectiveness.
Other Responsibilities
* Leadership or support of projects, meetings, etc. as directed by the Head of Process and Data Management.
Independence/Autonomy
* The leader acts independently and with high impact to drive results and organizational performance, seeking guidance only as needed.
* The leader is expected to proactively set priorities to achieve IMQS goals and objectives.
Required Minimum Education
Master’s degree in Science or Business.
Required Minimum Years of 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 or equivalent time and experience in a related healthcare R&D area. A minimum of 5 years’ experience in Medical Safety/Pharmacovigilance, process design, training design or related field is required.
Required Knowledge, Skills and Abilities
* Strong oral and written communication in English.
* Industriousness, self‑awareness, adaptability, attention to detail, and high teamwork capacity.
* Strong knowledge of worldwide (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 regarding business issues, strategic support, and organizational development as required by business urgency and growth.
* Significant collaboration, alignment and influencing across R&D Quality, OCMO, Global/Local Medical Safety, and various R&D functions.
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.
* Ability to embrace generational differences.
* Ability to operate in a virtual environment.
* Proven business acumen.
* Strong understanding of the digital and data science landscape.
* Exceptionally 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).
Preferred Knowledge, Skills and Abilities
* Process value‑stream mapping and analysis software proficiency.
Preferred Skills
None specified.
#J-18808-Ljbffr