Senior Manager, Synthetics Product Quality Integrator (PQI)

• Job title Senior Manager, Synthetics Product Quality Integrator (PQI)
• Function Quality
• Sub function Quality Assurance
• Category Senior Manager, Quality Assurance (P8)
• Location Titusville / Raritan / Horsham / Malvern / Gurabo / United States of America
• Date posted Jun 09 2026
• Requisition number R-080213
• Work pattern Hybrid Work

This job posting is anticipated to close on Jun 16 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.

Description

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 jnj.com

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.

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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 https://www.jnj.com/innovative-medicine

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 qualification and experience.
• Experience in one or more GMP Quality related disciplines is essential including, but not limited to, manufacturing and packaging operations, analytical testing and basic knowledge of new product introduction.

Experience and Skills

• Experience in a successful leadership role in building, inspiring and managing a global team and influencing across a matrix organization structure.
• 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.
• Hands-on experience with Artificial Intelligence applied to scientific problem solving, in a regulated environment, is a plus.
• Experience with scientific models for real-time-release, continuous manufacturing, new modalities (e.g. antibody drug conjugates), is a plus.

Other:

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

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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