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Senior Director, Product Quality (PQ) Value Optimizers & Later Stage (VO&LS)
Senior Director, Product Quality (PQ) Value Optimizers & Later Stage (VO&LS)-January 2024
Columbia
Jan 15, 2025
About Senior Director, Product Quality (PQ) Value Optimizers & Later Stage (VO&LS)

  Senior Director, Product Quality (PQ) Value Optimizers & Later Stage (VO&LS) - 2406163175W

  Description

  Cilag GmbH International is recruiting for a Senior Director, Product Quality (PQ) Value Optimizers & Later Stage (VO&LS). This role can sit at any Innovative Medicine site in North America or EMEA.

  At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Cilag GmbH International is part of the Janssen Pharmaceutical Companies.

  The Senior Director, Product Quality (PQ) Value Optimizers & Later Stage (VO&LS), is part of the Product Quality Management organization and will drive PQ VO&LS leadership. Position is entrusted with the overall quality strategy and accountability for all commercially marketed Janssen products in the VO&LS segment. The incumbent is accountable for developing and coaching a team of Product Quality Owners, to oversee all aspects of product quality and knowledge for his/her portfolio of products. The Senior Director PQ Value Optimizers & Late Stage is a member of the PQM Leadership Team.

  Key responsibilities include:

  Strategic development and successful execution of product quality strategies for all commercial products in the VO&LS segments, including:

  Assure the Product Quality Owners are a key member of the technical Value Chain teams representing end to end Quality (Drug Substance, Drug Product, Packaging, testing and Release).

  Assure business/quality processes are designed and executed to have key decisions on products proposed/decided, such as:

  All product related changes are initiated and evaluated by Value Chain teams or relevant technical teams.

  Value Chain teams involved in CAPA processes if product related.

  Initiate continuous quality improvements in all areas of the product (process, testing, handling, …) through a rigorous review of information such as Batch records, CAPA, Annual Product Reviews (APR), reconciliation reports, rejects, reworks, specification management etc

  Products are managed from cradle to grave including managing issues on the market.

  Value Chain teams assure product knowledge is integrated in the organization.

  Value Chain teams assures complaints are well managed, issues understood and trends in Product Complaints are understood and acted upon if needed.

  Assure Product Quality Owners are involved in the escalations for all products in the portfolio

  Attract and build a strong team of PQOs who can lead all quality aspects of their assigned products.

  Provide Coaching & Development to all Product Quality Owners in group, including succession planning, and performance reviews

  Provide a framework and guidelines wherein the Product Quality Owners are empowered to take decisions for their products.

  Own the Quality processes for delisting and divesting of commercial products.

  Build proactive, predictive quality product oversight. Proactive Product Quality Scans (PPQS) are executed timely on all the products under his/her responsibility and appropriate corrective actions are assigned and followed-up as needed.

  Collaborate with counterparts/peers to enable a smooth transfer of products from Launch & Grow to Value Optimizer and from Value Optimizer to Late Stage; ensure continued product knowledge transfer.

  Drive continuous improvement throughout department to ensure most efficient use of resources to deliver value-added support.

  Ensure that direct reports have training plans, their training is completed on time, and their training history documented. Annually approve the training plans for direct reports. Ensure that direct report training is completed on time and their training history documented.

  Qualifications

  Education:

  A Bachelor’s degree in Pharmaceuticals, Chemistry, Engineering, Sciences or similar

  An advanced degree and/or Business (MBA, MS or PhD) is preferred.

  Experience and Skills:

  Required:

  At least 15 years of senior level experience in Biotech/Pharmaceutical Industry and broad scientific expertise, having demonstrable experience in leading complex global programs and improvement initiatives, projects and groups of professionals is required. Multifunctional background preferred.

  Must have strong leadership skills and operate as a leader with global mindset, understanding and appreciation of the global /enterprise context.

  Relationship management, excellent coaching and collaboration skills are required.

  Must be an analytical and strategic thinker with the ability to create integrated sector wide solutions to align with sector and enterprise requirements.

  Influence, shaping solutions, negotiation and consultative skills are required.

  Must be a thought leader experienced in shaping solutions, with strong communication and collaboration/partnership skills.

  A minimum of 5 years of people management & talent development experience is required.

  The anticipated base pay range for this position is $187,000 to $322,000.

  The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

  Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

  Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

  This position is eligible to participate in the Company’s long-term incentive program.

  Employees are eligible for the following time off benefits:

  Vacation – up to 120 hours per calendar year

  Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.

  Holiday pay, including Floating Holidays – up to 13 days per calendar year.

  Work, Personal and Family Time - up to 40 hours per calendar year

  For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

  The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

  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 .

  Primary Location NA-US-New Jersey-Titusville

  Other Locations North America, Europe/Middle East/Africa

  Organization Cilag GmbH International (8525)

  Job Function Multi-Family Quality

  Req ID: 2406163175W

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