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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:

Quality

Job Sub** **Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a **Senior Manager, Quality Control, Stability Operations.** This position will be located in Titusville, NJ.

_At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity._

Position Summary:

The Senior Manager of QC Stability Operations oversees the daily functions of the Small Molecule Pharmaceutical Quality Control stability laboratory. Key responsibilities include planning, executing testing, analyzing and trending data, reporting findings, managing quality events and ensuring adherence to laboratory and equipment qualification and maintenance. This role also contributes to long-term planning, budgeting, forecasting, objective setting, and strategic business growth within Stability Operations.

The Senior Manager is accountable for maintaining quality and compliance across all laboratory activities, ensuring adherence to regulatory requirements.

Additionally, this position entails managerial responsibilities in alignment with the organization’s policies and applicable laws. Duties encompass interviewing, hiring, training employees, evaluating performance, rewarding and disciplining staff, and addressing complaints and conflicts.

Key Responsibilities:

General

+ Ensure a safe work environment that complies with all relevant environmental, health, and safety regulations.

+ Uphold Credo values by fostering a positive workplace culture.

+ Oversee the development plans for all team members.

+ Ensure the Stability Laboratory operates efficiently and effectively.

+ Manage long-term planning, budgeting, and forecasting activities.

+ Establish and implement SMART objectives for the team.

+ Assess team performance in relation to established goals and objectives.

+ Support the organization’s inspection readiness initiatives.

+ Ensure compliance with regulatory and internal commitments.

+ Execute managerial duties in alignment with organizational policies and applicable laws.

+ Optimize the management of team resources.

+ Stay informed on regulatory guidance and industry standards pertaining to the stability program.

Laboratory Management (60%)

+ Oversee stability laboratory operations, including program management, testing, data analysis, and report writing.

+ Ensure lean and robust processes comply with applicable cGMPs and IM Supply Chain Global Standards.

+ Manage method transfers and oversee commercial, annual, and development stability programs, including testing, trending, reporting, and ensuring appropriate staffing and training.

+ Lead quality investigations for OOT/OOS, CAPAs, and quality system metrics within Stability Operations, handling escalations as necessary.

+ Serve as a liaison to internal and external partners, facilitating health authority and DEA inspections.

+ Conduct budget planning and monitor the organization’s financial status.

+ Stay updated on regulatory guidance and industry standards related to stability testing, ensuring laboratory readiness for inspection.

+ Report on the status of established quality metrics.

+ Ensure facilities and equipment are maintained in optimal condition.

+ Maintain necessary site registrations, including FDA and DEA as applicable.

Resource Management (30%)

+ Train, develop, coach, and mentor employees in technical skills and career advancement.

+ Lead recruitment efforts and support hiring decisions.

+ Manage the performance of laboratory staff.

+ Establish performance objectives and development goals for the team.

+ Ensure adequate laboratory coverage to meet all operational needs.

Quality & Compliance (10%)

+ Serve as the lead Subject Matter Expert (SME) during internal audits and Health Authority inspections.

+ Ensure adherence to IM Quality global and local procedures, cGMPs, regulatory requirements, and industry standards.

+ Maintain in-depth knowledge of GMPs, CFR Part 11, ICH Q1 and current regulatory guidelines related to instrument calibration and computer systems validation (e.g., GAMP 5, USP <1058>, 21 CFR Parts 210 and 211).

+ Develop and review laboratory procedures to ensure compliance with both internal and external requirements.

Qualifications:

Education:

A minimum of a Bachelors or equivalent University degree is required. Advanced/ Masters degree preferred.

Required Knowledge & Skills:

+ 10+ years with a minimum of 5 years of people leadership is required, demonstrated skills in coaching, performance management and development

+ Ability to work with and lead others in a team environment

+ Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems

+ Expert knowledge of analytical technologies used in the QC laboratory

+ Knowledge of financial concepts and terminology associated with capital project/budget responsibilities of the position

+ Ability to communicate clearly and concisely to different levels of the organization

+ Experience interacting with regulatory agencies

+ Ability to establish and maintain cooperative working relationships with internal and external partners

+ Ability to quickly process complex information and often make critical decisions with limited information

+ Ability to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities

+ Ability to independently manage a portfolio of ongoing projects

+ Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols

+ Ability to work with using Microsoft Office applications (Outlook, Excel, Word, Project and Powerpoint)

+ Demonstrated experience with making sound scientific and business-related decisions.

+ Knowledge of current stability guidelines and industry best practices.

+ Relationship management, excellent coaching and collaboration skills

Preferred Knowledge & Skills:

+ Must have strong leadership skills and operate as a leader with a global mindset while understanding the impact at a platform level.

+ Must be a thought leader experienced in shaping solutions, with strong communication and collaboration/partnership skills.

Other:

+ This position may require up to 10% domestic travel.

+ This position has an estimated annual salary of $120,000-$207,000  $USD

+ Employees and/or eligible dependents may be 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.- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).- Employees are eligible for the following time off benefits:- Vacation – up to 120 hours per calendar year- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year- Holiday pay, including Floating Holidays – up to 13 days per calendar year- Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

The anticipated base pay range for this position is :

$120,000-$207,000  $USD

Additional Description for Pay Transparency:

• This position has an estimated annual salary of $120,000-$207,000  $USD • Employees and/or eligible dependents may be 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. - Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Employees are eligible for the following time off benefits: - Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year