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 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. 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 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 , internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: The anticipated base pay range for this position is : $122,000.00 - $212,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information