Director, PV Quality Management

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

2d•Hybrid

About The Position

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. 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium - Requisition Number: R-075920 UK - Requisition Number: R-075915 Switzerland - Requisition Number: 075918 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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, part of the IMQS organization, specifically focuses on and partners with the R&D and Pharmacovigilance and intensively 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. The IMQS-PDM team is responsible for GxP Quality Management System, GxP Personnel Qualification and Training by providing compliant, easy accessible process content, and for making learning tailored to the moment-of-need and at the point-of-use. As Director, Pharmacovigilance Quality Management, you lead a global team of PV Quality Management experts (PVQM 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 are a member of the IMQS-PDM LT and collaborate with the other PDM Leads, the PDM Head and other positions in R&D to ensure an efficient and compliant QMS is delivered. You play a strategic and operational role in coordinating the work of the PPQM team in a respective business unit. Where applicable, you will work in close collaboration with the business partners managing the delivery of the end-to-end connected business processes, applicable documentation and supportive training to implement quality procedural content and personnel qualification programs supporting the business partner objectives. You manage staff for process/qualification/training design and keep abreast of all PVQM needs, new materials, methods and digital/data science and automation techniques tailored to the business needs. As department head, you develop functional programs for PVQM staff and identify developmental needs including preparing personnel for more responsible positions and increasing effectiveness in present assignments.

Requirements

Master’s degree in Science or Business
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.
The ability to communicate well, both in oral and written form (in English) and using a variety of media, is required.
Demonstrated competencies include industriousness, self-awareness, adaptability, attention to detail and a high capacity for teamwork.
The role requires strong knowledge of worldwide (pre)clinical safety compliance regulations and guidelines, along with broad exposure to the array of regulatory and legal requirements within the life science industry.
Working conditions require resolution of complex problems within tight timelines.
This leader will be responsible for making decisions regarding business issues, strategic support, and organizational development, as required by business urgency and organizational growth.
The scope is across R&D Quality, the OCMO (Office of Chief Medical Officer) and Global/Local Medical Safety, and various R&D functions, and requires significant collaboration, alignment and influencing.
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
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
Proficiency with MS365 software
Proficiency with Project Management software

Nice To Haves

Proficiency with Process Value Stream mapping and analyzing software (preferred)

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 (Office of Chief Medical Officer) and Global/Local Medical Safety, Therapeutic Area and other business partners and stakeholders.
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/inspectional 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
Leadership or support of projects, meetings, etc. as directed by the Head of Process and Data Management.

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year