Senior Analyst, Records Management

TN United Kingdom; Leeds; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Analyst for Records Management in Leeds. This pivotal role focuses on developing and maintaining compliance programs in the MedTech sector, ensuring adherence to regulatory standards while fostering innovation in healthcare solutions. You will lead process improvements and support various projects across multiple sites, making a significant impact on the quality and efficiency of records management. Join a forward-thinking team that values your unique talents and commitment to enhancing patient wellness through smarter, less invasive treatments.

Qualifications

• 4-6 years’ experience in Records Management in a regulated industry.
• Strong understanding of GMP and/or ISO standards.

Responsibilities

• Develop and maintain the MedTech Records Management Program.
• Guide Business Units in executing MT-RIC program and process improvements.

Skills

Records Management

Quality Assurance

Regulatory Compliance

Process Improvement

Education

Bachelor's Degree

Job description

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Client:

Johnson and Johnson

Location:

Leeds, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

36e8207a3603

Job Views:

5

Posted:

05.05.2025

Expiry Date:

19.06.2025

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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 https://www.jnj.com

Job Function: Quality

Job Sub Function: Quality Systems

Job Category: Professional

All Job Posting Locations: Blackpool, Lancashire, United Kingdom, Leeds, West Yorkshire, United Kingdom

Job Description: We are searching for the best talent for a Senior Analyst, Records Management to be located in Leeds, Blackpool or any MedTech site. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.

Purpose: Develop and maintain the MedTech Records & Information Compliance (MT-RIC) Records Management Program in compliance with regulatory and legal requirements in addition to J&J WWRIM and Enterprise Quality standards. Guide Site Records Managers, Records Coordinators and departments across the MT Business Units in their execution of the MT-RIC program.

You will be responsible for:

1. Establish and maintain policies, procedures, work instructions, training materials, and records to support ownership of the MT-RIC processes at the MT Shared level.
2. Guide Business Units in implementing standard methodologies in the execution of the MT-RIC program.
3. Lead ongoing process improvement and cost reduction efforts across MT to drive business value and meet emerging business needs.
4. Guide Site Records Managers in local projects, including the adoption of True Copy scanning processes as well as automation and digital solutions.
5. Support WWRIM projects on behalf of MedTech.
6. Support audits in the Business Units for questions relating to the Shared MT-RIC procedures.
7. Lead remediation of quality events relating to Shared MT-RIC procedures.
8. Guide Business Units in resolution of quality events relating to local RIC procedures.
9. Develop and maintain metrics to measure health of MT-RIC program across MT.
10. Identify, maintain list of, and onboard Site Records Managers in the Business Units.
11. Support acquisitions, integrations, divestitures, new sites, site transfers, and site closures as required.
12. Assist MT-RIC Sr. Manager with MT-RIC process ownership responsibilities as required, including global MT-RIC communications, training delivery, Internal Compliance Assessment analysis, software implementation and retirement records management assessments, offsite storage vendor assessment tracking.
13. Communicate business-related issues or opportunities to next management level.
14. Follow all Company guidelines related to Health, Safety and Environmental practices as applicable.
15. If leading contractors, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
16. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
17. Additional opportunities to be assigned as business needs warrant.

Qualifications/Requirements:

• 4-year University/Bachelor's degree or equivalent is required.
• 4-6 years’ experience in Records Management or actively handling Quality or Manufacturing records in a regulated industry is required, preferably GMP and/or ISO.
• This position may be located at any MedTech facility.
• 5-10% domestic travel.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• Ireland - Requisition Number: R-012114
• Mexico - Requisition Number: R-012118
• Switzerland - Requisition Number: R-012101
• United States - Requisition Number: R-010414

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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. Johnson and Johnson is committed to providing interview process that are inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([emailprotected]) or contact AskGS to be directed to your accommodation resource.