Manager, Pre‑Clinical & Clinical Compliance

Johnson & Johnson Innovative Medicine • West Chester, PA

7d • $102,000 - $177,100 • Hybrid

About The Position

For the DePuy Synthes organization, the Clinical and Pre-Clinical QA Compliance Manager main job responsibilities include conducting 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 with applicable 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 the development lifecycle by partnering closely with stakeholders across R&D, Clinical Research, Regulatory Affairs, Medical Affairs and Quality teams.
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.

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 cross‑functional stakeholder groups.
• 15 to 20% domestic travel; audits will be conducted internally and externally

Nice To Haves

• Strong working knowledge of compliance requirements applicable to pre‑clinical 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, ).

Responsibilities

• Support compliance activities for GLP pre‑clinical 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.

Benefits

• 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.
• employees are eligible for the following time off benefits:

What This Job Offers

• Job Type: Full-time
• Career Level: Manager