Johnson & Johnson Innovative Medicine
Senior Managers Product Quality Integrator
Johnson & Johnson Innovative MedicineSwitzerland1 day ago
Full-timeQuality Assurance
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

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Latina, Italy, Little Island, Cork, Ireland, Mumbai, Maharashtra, India, Schaffhausen, Switzerland

Job Description

Johnson and Johnson Innovative Medicine is recruiting globally for 3 Senior Managers Product Quality Integrator (PQI), in the Product Quality Management Synthetics organization and reporting to the Sr Director PQ Launch&Grow.

The Senior Manager Product Quality Integrator 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 products 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. Supports PAI audits for the product assigned.
  • Assures product quality development through launch, understands the performance, and risk profile.
  • Supports the manufacturing 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).
  • 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 representing Global Quality including sites.
  • Identifies and provides balanced management of quality and compliance risks with business needs.
  • Collaborates and supports the organization on transformation initiatives.
  • 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.

Qualifications

  • Minimum 5 years of experience in quality, compliance or a scientific discipline in the pharmaceutical 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.
  • Demonstrate basic knowledge of financial management, budgeting, and business case calculation.

Experience And Skills

  • Project management experience.
  • 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.
  • Experience in leading a global team is a plus.
  • Demonstrated leadership in bringing products through development to launch is a plus.

Other

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

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):

Italy, Belgium, Switzerland, Ireland, India - Requisition Number: R-034335

United States - Requisition Number: R-034936

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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