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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our

employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

The Sr Analyst, 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 continuous improvement for proactive quality and/or business needs.

Key Responsibilities:

• Supplier Management
• 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 via clinical audits.
• The position will negotiate, review, and approve all relevant Quality Agreements between J&J and the External Manufacturers. The position assures implementation of these Quality Agreement.
• 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.
• Project Management/Process Improvement
• 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
• Batch Record Review
• 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.
• General
• The position will serve as a contact point within the QA Organization for project leaders (i.e. from GCO/CSC) with respect to the Quality Organization’s activities related to introduction of new clinical products to External Manufacturers/Suppliers.
• The position will review the relevant regulatory documents prior to submission and follow up on regulatory commitments (as required)
• 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.

Minimum Qualification

• Bachelors Degree in Science, Engineering and Technical subjects required.
• A Minimum of 6 years of experience within Pharmaceuticals or in an equivalent regulated environment.
• A Minimum of 4 years of experience within Quality or Compliance is preferred.
• 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%
• Location: Beerse, Belgium; Cork, Ireland; Latina, Italy

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.