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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 Assurance

Job Category:

Professional

All Job Posting Locations:

Bridgewater, New Jersey, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a **Manager External Clinical Supply Quality!** This position can be located in New Jersey, Pennsylvania or Beerse, Belgium.

Position Summary:

The _Manager, External Clinical Supply Quality,_ role is responsible for the quality and compliance in the selection, qualification, monitoring and management for external suppliers used for the packaging, labeling, over-encapsulation, and distribution of Investigational Medicinal products. Additionally, this individual will support the coaching and development within the team of employees supporting these functions, as well as continuous improvement for proactive quality and/or business needs.

Key Responsibilities:

+ This position will serve as a Quality contact point for the External Manufacturer/Supplier with respect to the J&J product in the External Manufacturer facility. The position holder will have signatory authority for QA in those projects.

+ Support or lead the qualification during selection and routine monitoring of suppliers including but not limited to leading clinical audits and the negotiation of Quality Agreements.

+ Contributes to the overall development, implementation, and execution of quality systems in support of the external suppliers.

+ Provide cGMP compliance support to suppliers by proactive management of quality using risk-based approaches, and supporting the investigation of quality issues and product quality complaints.

+ Drive phase appropriate GMP implementation at external packaging and label suppliers in early and late phase development to fulfill the business requirements.

+ Builds relationships and collaborates with suppliers and internal stakeholders to drive compliance and continuous improvement initiatives.

+ Monitor trends, identify issues, recommend, and implement appropriate actions.

+ Maintain and/or approve GMP documentation at suppliers and within Johnson and Johnson including but not limited to supplier account records, audit records, investigations, and CAPAs.

+ Leads or serves in teams or major cross-functional project initiatives to proactively improve quality/compliance or drive business goals.

+ Develop, implement, review and/or approve SOPs associated with clinical packaging and labeling

+ Oversees the batch record review process and monitor the status of KPIs. Collaborates within Clinical Supply Chain to resolve batch record discrepancies or errors as it relates to Good Documentation Practices.

+ Ensure that manipulated drug products and finished products produced for clinical trials are released in accordance with the cGMP and the product specification file and in a timely manner to prevent patient or trial impact.

+ Remain current with EMEA/FDA and local GMP regulations, guidelines, and quality practices associated with the pharmaceutical industry.

+ Apply cGMP regulations and other FDA/EMEA and international requirements to all aspects of the position.

+ Maintain compliance with all company policies and procedures.

Qualifications:

Education:

A minimum of a Bachelors or equivalent University Degree is required with a focus in Science, Engineering and Technical subjects preferred.

Required:

+ A Minimum of 8 years of experience within Pharmaceuticals or in an equivalent regulated environment.

+ A Minimum of 4 years of experience within Quality.

+ Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

+ Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

+ Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

+ Extensive knowledge and full understanding of the Quality Assurance tasks associated with of pharmaceutical manufacturing and packaging, release, and distribution processes.

+ Strong knowledge of cGMP, pharmaceutical legislation, regulations, and guidelines (i.e. US CFR, ICH, Eudralex volume 4-annex 13)

+ Strong knowledge of the required Quality and Production systems used within the role including but not limited to TruVault, COMET

+ Excellent computer proficiency e.g. MS Office

+ A strong understanding and experience within leading audits of external suppliers

+ Ability to take ownership for and lead the resolution of complex Quality and Compliance issues with respect to External Manufacturing

+ A basic to strong understanding of API and Finished Product Manufacturing

+ Strong experience in leading, coaching, and developing a team

+ Ability to handle multiple and/or complex stakeholders and priorities.

+ Ability to work independently and to meet project objectives and timelines.

+ Ability to work within multiple cross functional teams with global composition.

+ Fluent in written and spoken English

Other requirements

Occasional travel to the supplier for audits and/or site visits, estimated to be 10-15%

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- $173,500  USD$

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