Product Quality Integrator (PQI) Director.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Johnson & Johnson is recruiting a Product Quality Integrator (PQI) Director.

The PQI Director has end-to-end accountability for the quality strategy and quality aspects of new products from Early Development through commercialization for an assigned portfolio of products. Develops and leads the quality strategies to support new platforms that are in- licensed or developed within the J&J Supply Chain or other J&J operating companies. Develops and/or translates creative, innovative and compliant approaches to introduce new products, right-first-time and resulting in first-pass approval. Helps resolve issues and facilitates timely advancement of new products to ensure that they are filed and launched on time. Serves as the global resource to the entire Quality Organization to provide guidance, training, and consultation on new product development. Serves as a consultant and mentor to colleagues and management.

Key Responsibilities

• Ensures product quality for patients.
• Represents Global Quality on the CMC and Value Chain (VCT) Teams. Provides liaison between VCT and Analytical group. Serves as the single point of Global Quality contact for an assigned group of products. Establishes and develops strong working relationships with business partners (within SC, TDS, and J&J) on a global basis. Drives communication within Q&C.
• Represents Product Quality Management (PQM) in a leadership role in various multidisciplinary project teams, committees and special projects as assigned. Provides oversight for the development and maintenance of specific programs and/or projects.
• Ensures Quality milestones and Quality stage gate deliverables are achieved. Quality reviewer/approver of health authority submissions (i.e., BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Supports PAI audits for the product assigned.
• Has line management responsibilities, leading a group of Senior Managers or Managers. Is responsible for one or more products directly and for other products through the team.
• Mentors within Product Quality and Quality Integrator sub-team.
• Defines and coordinates the necessary Quality resources.
• Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device:
• Assures product quality development through launch, understands the performance, and risk profile.
• Supports the sites, represents the sites on CMC and VC teams.
• Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
• Participates in Product Strategy Reviews, in alignment with the Supply Chain Product Strategy with other existing strategies (J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.).
• Ensures that Global Quality processes are followed, maintained and communicated, during development and across sites (e.g. PPQS, criticality analysis, complaints).
• Partners with Quality Owner to complete Transfer of Ownership activities.
• Remains current in knowledge, skills and industry trends. Trains on new regulations, guidelines, procedures and processes. Makes a positive contribution by making suggestions for improvement.
• Demonstrate high knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
• Gives inputs and provides guidance on production quality and packaging application related subjects.
• Presents project updates to Quality leadership for Global Q&C alignment in advance of Stage Gates and commercial sourcing decisions.
• Escalates issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, participates and/or leads Issue Management teams. Supports field actions / recalls as needed.

Decision making and Problem Solving:

• Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
• Identifies and provides balanced management of quality and compliance risks with business needs.
• Gives input to the development of new strategies and implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
• Collaborates and supports the organization on transformation initiatives.
• Is aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
• Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of high risk, uncertainty and ambiguity.
• Is expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs, thus providing the best total value to the company.
• Minimum 10 years of experience in quality, compliance or regulatory affairs in a regulated industry.
• Minimum of Master / Bachelor’s degree in a scientific discipline, and it is essential that the individual has excellent scientific & technical capabilities based on a combination of qualification and experience.
• Experience in more than three quality related disciplines is essential including, but not limited to, manufacturing and packaging operations, analytical and micro testing and commercial distribution, basic knowledge of new product introduction.
• Demonstrate medium knowledge of financial management, budgeting, and business case calculation.

Experience and Skills

• Experience in a successful leadership role in building, inspiring and managing a global team and influencing across a matrix organization structure.
• Excellent communication and organization skills required. Strong presentation, written and oral communication skills as well as the ability to meet due dates. Attention to detail and analytical / problem-solving skills.
• Business oriented, independent, and driven.

Other:

• Proficient in English.
• Travel: approx. 10% of time based on specific business needs.

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 o ur employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.