Senior Manager, Synthetics Product Quality Integrator; PQI

Position: Senior Manager, Synthetics Product Quality Integrator (PQI)
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 Med Tech, 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

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is recruiting for a Senior Manager, Synthetics Product Quality Integrator (PQI) in Titusville, NJ, with considerations given to other US based J&J sites at the discretion of the business.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

The PQI senior manager has end-to-end accountability for the quality strategy and quality aspects of a product portfolio from development through end-of-lifecycle.

Develops and leads the quality strategies to support new products and/or platforms. Leads a global quality and compliance team responsible for clinical/commercial product quality. Discusses, reviews and approves product documentation such as specifications, investigations, regulatory filings, maintaining the highest quality and compliance standards.

Works with high performing cross-functional teams to identify risks and mitigations, resolve issues, enabling on-time regulatory submissions and launches.

Connects with stakeholders, serving as the Product Quality single point of contact, providing regular updates to peers and leaders.

Key Responsibilities

* Is guided by Our CREDO.

* Ensures high quality products for patients.

* Represents Global Quality in CMC and Value Chain Teams. Establishes and develops strong working relationships with business partners globally.

* Ensures Quality milestones and Quality stage gate deliverables are met on time. Reviewers / approves health authority submissions (i.e. IND, NDA, MAA) and filing response documents.

* Provides Quality inputs to commercial sourcing decisions.

* Leads a global quality and compliance team responsible for clinical/commercial product quality. Working proactively to understand risks, develop mitigation strategies and communicating with management.

* Supports the preparation of mock PAI and PAI audits for the products assigned and participates in audits as needed.

* Ensures that Global Quality processes are followed, maintained and communicated across sites (e.g. criticality analysis, escalation, complaints).

* Represents Quality and/or leads project teams as assigned.

* Remains current in knowledge, skills, industry trends, draft guidelines and new regulations.

* Escalates issues when appropriate. Works with cross functional teams to coordinate and hold Escalation meetings, participates and/or leads Issue Management teams. Supports field actions / recalls as needed.

Qualifications

* Minimum 7 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…