Job Description
Director, PV Quality Management located in Titusville, NJ, Raritan, NJ, Beerse, Belgium, High Wycombe, UK, Maidenhead, UK, Allschwil, Switzerland or Schaffhausen, Switzerland.
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.
Learn more at https://www.jnj.com/innovative-medicine
Locations
* Belgium - Requisition Number: R-075920
* UK - Requisition Number: R-075915
* Switzerland - Requisition Number: 075918
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.
* Ensure the GxP/GPvP Quality Framework evolves with 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.
* Lead and support projects, meetings, etc. as directed by the Head of Process and Data Management.
* Act independently with high impact to drive results and organizational performance.
Qualifications
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. A minimum of 5 years’ experience in the field of Medical Safety/Pharmacovigilance, process design, training design or related field.
Knowledge, Skills and Abilities
* 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, along with broad exposure to regulatory and legal requirements within the life science industry.
* Ability to resolve complex problems within tight timelines.
* Responsible for making decisions regarding business issues, strategic support, and organizational development as required by business urgency and organizational growth.
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.
* 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).
Salary
€119,200.00 - €204,355.00 (primary posting location).
Belgium – 119,200 – 204,355.
Benefits
* Annual bonus with set target (% of pay) depending on pay grade/location, based on employee and company performance.
* Vacation days.
* Parental leave for a minimum of 12 weeks.
* Bereavement leave.
* Caregiver leave.
* Volunteer leave.
* Well‑being reimbursement.
* Programs for financial, physical and mental health.
* Service anniversary and recognition awards.
* Insurance plans for employees and eligible dependents.
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