AddressJ&J Innovative Medicine, part of the Johnson & Johnson Family of Companies, is recruiting for a Manager PPQME (Process and People Qualification Management Expert) located in UK or Belgium.
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. Learn more at https://www.jnj.com/
The Manager PPQME (Process and People Qualification Management Expert) guides global business owners and R&D Quality team members to deliver compliant processes and training in accordance with the J&J Innovative Medicine (JJIM) standards. This includes the timely end to end delivery of process design, procedural document development, training and qualification strategy, training delivery and final implementation into the organization. The Manager reports to the Director, Process & Personnel Qualification Management and supports the R&D Quality organization and other R&D business partners such as J&J Innovative Medicine, OCMO. The Manager performs required change management, risk management, resolves issues for projects, and performs a detailed analysis of business processes across a variety of quality processes.
Key Responsibilities:
- Map, analyze, develop, and implement compliant and efficient end-to-end complex processes and related training and qualification as part of the GxP Quality Management Framework
- Represent R&D Quality/PDM, serve as a bridge between business partners, quality groups and governance to ensure the GxP Quality Framework evolves with the business and regulatory requirements and needs, including changes, CAPA, investigational/inspectional requests
- Support the implementation of the transformation roadmap 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 or support projects, meetings, etc. as directed by the Head of Process and Data Management/Head of Process & Personnel Qualification Management
Qualifications
Education:
- A minimum of a Bachelor's Degree or equivalent required
Experience and Skills:
Required:
- A minimum of 8 years’ experience in a medium to large-scale organization, including 5 years 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 3 years’ experience in the field of process design, training design or related field is required
- The role requires knowledge of Pharmacovigilance compliance regulations and guidelines, along with broad exposure to the array of regulatory and legal requirements within the life science industry
- Strong leadership skills including significant networking and relationship building skills, the ability to build an open and inviting environment, ability to accept generational differences and to operate in a virtual environment and a basic understanding of the digital and data science landscape
- This expert must be able to effectively operate in a matrix environment and influence and interact with business partners on a regular basis
- The ability to combine business needs with functional objectives is required
Preferred:
- Proficiency with Process Value Stream mapping and analyzing software
- Excellent written and verbal communication skills, communicates clearly, making the complex clear and compelling to all levels of the organization in both written and oral forms
- Coordination of Enterprise-wide training programs
Other:
- International travel: 10%
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com
