SENIOR MANAGER PRODUCT QUALITY INTEGRATOR

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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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Key Responsibilities The Senior Manager, Product Quality Integrator has end-to-end accountability for the quality strategy and quality aspects for new products from Early Development through commercialization in Launch and Grow for an assigned portfolio of products.
Represents Global Quality on the CMC and Value Chain Team (VCT).
Serves as liaison between VCT and Analytical group.
Serves as the single point of Global Quality contact.
Drives communication with all Q&C partners.
Ensures Quality achievements and Quality stage gate deliverables are achieved.
Quality reviewer/approver of health authority submissions (i.
.,BLA, NDA, MAA) and associated HA questions on the filings.
Support PAI and agency audits for the product assigned.
Defines and coordinates the vital QA resource for global and local QA of their assigned products.
Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device.
Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
Demonstrate knowledge of product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
Gives input to the development of new strategies.
Implements and deploys strategies.
Aids in the creation of product portfolio guidelines on the control strategy for development 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.
Qualifications Education and Experience.
Minimum of Master / Bachelor´s degree in a scientific field, and crucial you have excellent scientific & technical capabilities based on combination of qualification and minimum 7 years of experience in a regulated industry.
Experience in at least one quality related subject area is a requirement including, but not limited to, manufacturing and packaging operations, analytical and micro testing and commercial distribution, basic knowledge of new product development.
Experience within ADC (Antibody Drug Conjugates) is a nice to have.   Demonstrate medium knowledge of financial management, budgeting, and cost benefit calculation.
Fluent in English.
Leadership & Behavioral Competencies Consistent track record in successful leadership role in building, inspiring and leading a global virtual team and influencing partners across a cross-functional organization structure.
Well-developed leadership skills and shown efficiency to influence others in a cross-functional environment.
Excellent communication and organization skills required.
Excellent presentation, written and oral communication skills as well as the ability to meet targets.
Strong attention to detail and analytical / problem-solving skills Business oriented, independent and driven.
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.