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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 https://www.jnj.com

Job Function:

Supply Chain Manufacturing

Job Sub** **Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

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

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:

+ Minimum of a Bachelor’s degree required, Advance degree is preferred

Experience and Skills:

Required:

+ Minimum six (6) years of experience in leadership role in managing a team, developing talent, and championing inclusion

+ Minium six (6) years of relevant professional experience

+ Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for manufacturing

+ Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and 610

+ Proficiency with Microsoft Office applications such as Outlook, Excel, Word, and PowerPoint.

+ Excellent problem-solving and analytical skills

+ Effective communication and collaboration across departments with presentational skills

+ Attention to detail and ability to multitask in a fast-paced environment

Preferred:

+ Experience in Lentiviral Vector and/or Cell/Gene therapy processing

+ Experience and knowledge in a Good Manufacturing Practices (GMP) environment

Other:

+ May require up to 10% domestic travel

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. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.