Senior Manager, Synthetics Product Quality Integrator (PQI)

Johnson & Johnson • Titusville, NJ

19h • Hybrid

About The Position

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. 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.

Requirements

• 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 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.
• Proficient in English.

Nice To Haves

• 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.

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.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior