Lentiviral Vector (LV) Investigations Manager

Lentiviral Vector (LV) Investigations Manager

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.

We are searching for the best talent for a Lentiviral Vector (LV) Investigations Manager to join our team in Raritan, NJ.

Summary :

LV Investigations Manager leads all aspects of a team of individual contributors and / or supervisors in support of activities related to investigations, CAPAs and Quality Systems. Ensuring GMP compliance, accuracy and key quality deliverables are completed in accordance with required timelines. Carries out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures.

Key Responsibilities :

• Develops strategy for routine investigations data collection, analysis, track & trend deviations, manage quality system metrics for deviations and report at site and cross-site levels.
• Provide technical and managerial leadership to drive efficient, compliant, and effective Lentivirus investigations team.
• Supports and owns metric related actions and activities. Responsible for driving site metrics and quality topics and proactively identifying issues for management for review.
• Review / approve documents as an investigations department subject matter expert (SME). Support investigation of nonconformances, CAPAs and change controls.
• Provides guidance on key controlled documents for QMS activities, escalations, and significant issues.
• Ensures all non-conformances are thoroughly investigated with root cause identified and appropriate CAPA's implemented. Drives continuous improvement in Root Cause Investigation Process.
• Advises business partners on compliance with all company and site policies standards and procedures.
• Collaborates with business partners to resolve complex issues
• Serves as a lead and / or SME for the investigations team during internal audits and external inspections
• Accountable for ensuring that record cycle times are met within quality functional areas. Collaborate with team to address delays or issues and identify and implement efficiencies to reduce E2E record cycle times.
• Responsible for maintaining a high competence team through performance management, succession planning, talent management, recruiting, staffing and making hiring decisions, and training and development processes.
• Creates and maintains an environment that serves as a learning atmosphere and fosters diversity, equity, and inclusion.

Qualifications : Education :

Experience and Skills :

Other :

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.

The anticipated base pay range for this position is : $100,000 to $172,500

Additional Description for Pay Transparency : Subject to the terms of their respective plans, employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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)). 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 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 Condolence Leave 30 days for an immediate family member : 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below.