DIRECTOR PQI

Janssen Supply Group, part of the Johnson & Johnson Family of Companies is recruiting for a Director, Product Quality Integrator, Biologics Launch & Grow in Horsham, Pennsylvania, Leiden, the Netherlands, Beerse, Belgium, Schaffhausen, Switzerland, and Cork, Ireland.
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.
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The Director Product Quality Integrator (PQI) has end-to-ended accountability for the quality strategy and quality deliverables for new products from Early Development through commercialization for an assigned portfolio of biologics products.
Develops strategies and leads quality subteams supporting products that are in-licensed or developed within J&J Innovative Medicines.
Develops and/or translates innovative and compliant approaches to introduce new products right first time with first-pass approval.
Helps resolve issues and facilitates the timely advancement of new products to ensure they are filed and launched on time.
Serves as a global resource to the entire Quality Organization to provide guidance, training, and consultation on new product development.
Are you interested in joining a dynamic team delivering outstanding results to our customers? Apply now for this exciting opportunity! Key Responsibilities.
Ensures product quality for patients Represents Global Quality on the CMC and Value Chain (VCT) Teams.
Serves as the single point of Global Quality contact for an assigned group of products with high complexity.
Establishes and develops strong working relationships with global collaborators (within the supply chain, R&D, and J&J).
Drives communication within quality & compliance.
Represents Product Quality Management (PQM) on various multidisciplinary project teams, committees and special projects as assigned.
Ensures Quality milestones and CMC Stage Gate Quality deliverables are achieved.
Quality reviewer/approver of health authority (HA) submissions (i.
., BLA, NDA, MAA) and associated HA questions on the filings.
Approves filings and questions for secondary filings.
Supports PAI audits.
Has line management responsibilities leading a group of Senior Managers or Managers.
Responsible for one or more products directly and for other products through their team.
Leads a comprehensive Global Quality subteam that ensures Quality throughout clinical, DS, DP, FF & device.
Maintains the flow of communications between Global Quality and the CMC and VC Teams.
Drives communication with all Q&C collaborators.
Ensures product quality development through launch, understand the performance, and risk profile.
Ensures that Global Quality processes are followed, maintained and communicated, during development and across sites (e.
.
PPQS, criticality analysis, complaints).
Escalates issues when appropriate.
Works with cross functional teams to coordinate and hold Escalation meetings.
Participates in and/or leads Issue Management teams, as required.
Drives/coordinates decisions on behalf of Global Quality including sites.
Expected to bring creative solutions to define a compliant quality strategy with flexibility for complex business needs, thus providing the best total value to the company.
Qualifications Education.
A minimum of a Bachelor’s degree in technical, scientific, or engineering is required.
A focus in pharmacy, biology, biochemistry, biotechnology, or engineering preferred.
A Master’s degree is preferred.
Experience and Skills.
Required.
A minimum 10 years of related work experience in pharmaceutical or biotechnology industry.
Experience in Quality Assurance and/or Quality Control, pharmaceutical manufacturing/packaging operations, analytical testing or commercial distribution Individual must have excellent scientific and technical capability based on a combination of qualification and experience Excellent communication and organization skills required.
Strong presentation, written and oral communication skills.
Preferred.
Experience leading, inspiring, and influencing across organizations.
Superb analytical / problem-solving skills.
Independent and driven.
Other.
Proficient in English.
This position may require up to a 10% travel domestically and/or internationally 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.
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