Senior Compliance Specialist

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

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工作职能：Legal & Compliance

作业子功能：Enterprise Compliance

职位类别：Professional

所有职位发布位置：Xian, Shaanxi, China

职位描述：
Senior Compliance Specialist (Xian China)

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in pharmaceutical, and medical devices markets and have the skills and resources to tackle the world's most pressing health issues.

The Innovative Medicines Regulatory Compliance organization is recruiting for a Senior Compliance Specialist. This position will be based in the Xian site, China.

DESCRIPTION

The Senior Compliance Specialist reports directly to the Manager, IMRC-SBC (China).

This position will execute the internal audit program at the Xian site, prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc.), provide compliance subject matter expertise to the manufacturing site and site-based projects, deploy compliance initiatives for the site in alignment with Innovative Medicines Regulatory Compliance.

RESPONSIBILITIES

· Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)

• Execute compliance walk-throughs (e.g. GEMBA)

• Evaluate responses to internal audits

• Enter internal audit data into COMET

• Enter GEMBA findings into the appropriate database

· Facilitate and/or support external GMP audits and inspections (Health Authority, Customer). Including:

• Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)

• Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)

• Review site response and associated CAPA for Health Authority inspections.

• Provide input to daily inspection summaries, as needed.

· Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. Implement J&J Compliance Standards (e.g. Audit/Inspection Management) and partner with sites on J&J standard implementation.

· Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.

· Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.

· Partner with site for execution of proactive compliance scans.

· Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc.) to proactively identify risks and drive compliance improvement across the site.

· As applicable, monitor progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.)

· Collaborate with other groups in IMRC and JJRC to support execution of independent audits and special investigations. Support site during ERC audits (e.g. document review, front/back-room support). Review and provide input to site response, and associated CAPA, to ERC audits.

· Ensure timely and accurate reporting of compliance metrics.

· Lead the Inspection Readiness Governance meetings.

· Coordinate compliance training for the site.

· Connect with external groups to benchmark industry standards.

· As needed, co-authors, review, and revise compliance procedures.

· As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.

REQUIREMENTS

· Bachelor’s degree in science or related field is required.

· Minimum of five (5) years of experience in GMP-regulated industry and at least one (1) year of regulatory compliance experience is required.

· Strong knowledge of global GMP regulations is required.

· Strong analytical skills. Ability to clearly articulate issues.

· Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community.

· Delivers on commitment timelines and has high sense of urgency.

· Experience preparing for inspections, managing inspections and/or supporting inspections.

· QA/RA certification is preferred.

· Experience performing internal or external audits is strongly preferred.

· Experience in change management and project management.

· Ability to communicate in both Chinese and English is strongly preferred.

Required Skills:

Preferred Skills:
法律服务, 法律职能, 风险规范, 沟通, 合规管理, 合规框架, 解决问题, 流程优化, 批判性思维, 企业调查, 商务写作, 商业行为, 审计报告, 审计管理, 审计和合规趋势, 训练, 以人为本