Description
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/.
At Johnson & Johnson Innovative Medicines, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
This position will lead a team of Quality Assurance professionals that have Quality and Compliance oversight on multiple External Manufacturers involved in the development of products and in clinical production. The team is global and manages large molecules as well as various advanced therapies using new technology platforms.
This position works closely with the management of External Supply Integration, other Quality Assurance functions, the internal Product Development organization, Technical Operations, internal Janssen sites and other partners.
Main responsibilities
- Provides strategic direction and assistance in:
- The selection, auditing, qualification and monitoring of external manufacturers.
- The negotiation and review of all relevant quality agreements between Janssen and the external manufacturers.
- The technology transfer and improvement of existing manufacturing processes.
- The overall development, implementation, and execution of quality system improvements to reduce quality and compliance risk in the manufacture pack and labeling and testing of clinical and development products.
- Investigations, issue resolution, CAPA and change control with external manufacturers.
- Quality due diligence assessments as part of license and acquisitions.
- The monitoring of trends to pro-actively identify issues and recommend and implement appropriate actions.
- Influencing and building relationships with external manufacturers and internal parties to achieve objectives.
The Director will coach, train, lead and develop the group to meet quality, compliance, development and clinical business requirements and serves as a mentor for people managers and associates in the organization.
Qualifications
- Bachelor’s Degree with a minimum of 8 years in an FDA regulated environment is required and in a pharmaceutical manufacturing or quality environment, including experience working in an R&D environment.
- Extensive knowledge of Quality Assurance, Quality Control and Compliance. Experience in large molecule or Advanced Therapies manufacturing is preferred.
- Ability to operate with a minimum of supervision and lead the resolution of complex Quality and Compliance issues with respect to External Manufacturing.
- Must be able to evaluate and interrelate with multiple quality systems associated with the different external manufacturers and determine suitability against J&J global standards.
- Must be able to travel to external manufacturers to provide cGMP assistance and quality oversight, as required, in support of Janssen projects.
Location: US East Coast or Europe close to a Johnson & Johnson Innovative Medicine site
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.