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Clinical and PreClinical QA Compliance Manager

Job Description:

DePuy Synthes is recruiting for a Clinical and Pre-Clinical QA Compliance Manager, to belocatedin one of the following locations: Raynham MA or Palm Beach Gardens FL or West Chester PA.

Job Overview

For the DePuy Synthes organization, the Clinical and Pre-Clinical QA Compliance Manager main job responsibilities includeconducting internal and external GCP Clinical Quality Assurance (QA) audits which include system, program and clinical site investigator sites as well as GLP Preclinical Quality Assurance Supplier Audits.

Additionally, this role will include GCP projects relative to supporting compliance activities across clinical research programs within Orthopedics. This role will support the clinical study design, execution, documentation, and oversight in compliance withapplicable external regulations, quality standards, and internal policies. This particular position plays a critical role in protecting patient safety, ensuring data integrity and enabling compliant advancement of products through thedevelopmentlifecycle by partnering closely with stakeholders across R&D, Clinical Research, Regulatory Affairs, Medical Affairs and Quality teams.

The Role
In the role as Clinical and Pre-Clinical QA Compliance Manager, GCP Quality activities include GCP Clinical and GLP Preclinical audits will include the following:

• Preparation prior to the audit, connecting with the clinical research team identified and providing advanced notice including securing availability to conduct the audit
• Conducting the audit including interviewing the clinical research team and reviewing documents requested
• Facilitating an audit close-out meeting and issuing a audit report including observations cited for follow-up as applicable
• Follow-up as required, on the status/closure of audit findings

The role requires profound understanding of how the GCP requirements are applied into practice, especially with focus across North America and European requirements as well as interpretation of ISO14155 and ISO13485 as well as the FDA 21 Part 820.
The role includes hands on GCP Quality and GLP Quality activities such as support issue identification and mitigation to our many stakeholders as well as performing audits alone or together with own team members or with support from neighboring teams. The role requires strong collaboration capabilities in a matrix environment across various Quality and Clinical and Preclinical departments.
Key Responsibilities

• Support compliance activities for GLP preclinical and GCP clinical programs, ensuring adherence to regulatory and quality requirements are met according to medical device standards internally and externally
  • Assist with providing clinical compliance oversight and reviews as assigned for clinical study protocols, clinical study manuals, reports, and clinical supporting documentation.
  • Partner with R&D, Clinical, Regulatory Affairs, and Quality teams to support compliant study execution and lifecycle management.
  • Interpret applicable regulations and standards and translate them into practical compliance requirements for study teams.
  • Support GCP clinical and GLP clinical quality assurance internal audits, external audits
  • May support GCP External Clinical Audits/Inspections from Health Authorities including FDA and /or notified body
  • Monitor compliance risks, trends, and findings and escalate as necessary to management
  • May be assigned to facilitate quality control activities, including risk assessment, deviation management, and Corrective and Preventive Actions (CAPA) as applicable
  • Ensure consistent application of global and local compliance procedures, controls, and governance
  • Participate in maintaining the GCP Quality strategies by aligning with global GxP standards, DePuy Synthes Quality Management Systems and DePuy Synthes Quality Policy
  • Develop and execute the annual GCP Clinical and GLP Preclinical audit plan in partnership with DePuy Synthes Regulatory Compliance management and present to Clinical Research stakeholders for awareness
  • May execute as assigned, clinical audits based on requirements needed irrespective of the audit schedule and based upon clinical risk identification
  • May contribute to the standardization, harmonization, and scalability of GCP and GLP Quality Audit processes as applicable
  • May be tasked to lead quality improvement initiatives to enhance processes; technical enablement may be required
  • May deliver as tasked, input to the Quality Management Review, as applicable.
  • Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills
    

Requirements:

• Bachelors required, with MS or other higher degree preferred in Biological or Natural Sciences or equivalent
• 6 to 8 years of progressive experience in a GCP Clinical Quality / GCP Clinical Compliance or Clinical Auditing or similar function with proven leadership experience is required within a medical device regulated industry
• Considered to be a Domain Expert within GCP with the ability to manage complex compliance topics across crossfunctional stakeholder groups.
• Travel Expectations: 15 to 20% domestic travel; audits will be conducted internally and externally

Preferred:

• Strong working knowledge of compliance requirements applicable to preclinical research GLP Preclinical experience preferred
• Orthopedics medical device experience is strongly preferred
• Experience as Lead Auditor within GCP is an advantage
• Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills
• Technical skills such as development of dashboards, PowerBI and/or Tableau
• Quality, Project Management, Regulatory certifications (e.g., ASQ CQA, RAC, PMP, ).

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

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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.

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Required Skills:

Preferred Skills:

Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Process Improvements, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Risk Management, Technical Credibility, Third-Party Auditing

Job Function:

Quality

Job Sub Function:

Quality & Compliance Audit

Job Category:

Professional

Primary Job Posting Location:

Raynham, Massachusetts, United States of America

Additional Job Posting Locations:

Palm Beach Gardens, Florida, West Chester, Pennsylvania, Raritan, New Jersey and Warsaw, Indiana within the United States of America

Legal Entity Name:

6149-DePuy Synthes Products Inc. Legal Entity

Pay Grade:

30

The anticipated base pay range for this position is :

$102,000.00 - $177,100.00

Additional Description for Pay Transparency:

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)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Required Skills:

Preferred Skills: