Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : Senior Compliance Manager, Medical Device (Asia Pacific)
Job Description
The Senior Compliance Manager, Medical Devices (Asia Pacific), reports directly to the Director, J&J Regulatory Compliance (Asia Pacific), and will be a member of the J&J Regulatory Compliance (Asia Pacific) team and a member of the Global Surgery segment Regulatory Compliance team.
The Senior Compliance Manager is responsible for establishing and maintaining a robust Compliance Program for a group of manufacturing sites in the Asia Pacific region to ensure compliance to local and international regulatory standards and J&J policies and standards.
The Senior Compliance Manager will work closely with key stakeholders such as Site Quality Leads, Site Operational Leads, Business/Franchise and Supply Chain Compliance and Quality Leads.
The Senior Compliance Manger will manage the Site Compliance team at the manufacturing sites.
Responsibilities
- Establish and maintain a robust Compliance Program for Medical Device manufacturing sites in Asia Pacific to ensure compliance to local, national and international regulatory standards, company policies and procedures, J&J corporate requirements.
- Internal Audits program management – Partner with sites and franchise Compliance teams to coordinate the implementation of an effective internal audit program schedule, ensure audits implemented on time and by qualified personnel (including knowledge, experience, and independence)
- Establish and maintain regulatory inspection readiness plan at each manufacturing site within the region in preparation for any regulatory inspection (internal corporate or external audits). Support manufacturing site regulatory inspections as required
- Partner with Franchise Compliance team on the formulation of responses to regulatory agencies / corporate audits in order to address manufacturing site related observations. Collaborate with quality / operations partners in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions
- Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the Quality System and its compliance to applicable regulations and standards. Ensure results of monitoring process are routinely communicated to management through Site Management Review process.
- Manage the relationship and contract with the notified bodies from a compliance perspective.
- Provide leadership, oversight and strategic guidance from the regional perspective for significant regulatory compliance issues in the manufacturing sites, EMs and suppliers. Oversight may include independent monitoring and reporting.
- Standardize and leverage MD Regulatory Compliance policies, practices, metrics and resources across the segment
- Provide input to the Franchise Compliance lead on the classification of all Regulatory Health Authority inspections and supply chain-related observations at all the manufacturing sites and severity of field actions within the region and to Quality Operations on manufacturing plant-related recall activities as required
- Coordinate compliance training as required.
- Report and review in company databases for Field Action, Regulatory Inspection and QSCAN (Quality System Compliance Analysis) ensuring data accuracy, timeliness and completeness as applicable. Enable execution of QSCAN process per schedule / requirement
- Manage the team of site compliance leads and manage the site compliance team budget.
- Enable/Support implementation of policies and standards across all sites within scope of role in the region.
- Ensure implementation of the escalation processes as aligned with Enterprise escalation processes. Assure operating units are fully complying with escalation processes
- Support Segment Compliance dashboards and reporting preparation for the Segment and Enterprise Q&C organization as necessary.
- Represents J&J Regulatory Compliance (Asia Pacific) (JJRC APac) in applicable Q&C & supply chain leadership forums and councils.
- Provide regulatory compliance support to ad hoc committees and projects as necessary.
- Regulatory Intelligence
- Support a network of subject matter experts providing input to, appropriately influence, and Interpret requirements of Regulatory Agencies around the globe regarding regulations, regulatory pathways, or approach.
- Work with Franchise Compliance to identify, prioritize and ensure implementation of new and revised regulatory requirements and expectations.
- Support implementation plans for regulatory changes including routinely monitoring and verification of implementation activities.
Candidate Profile
- Graduate degree in science or related field is required. Post-graduate degree in science, pharmacy, engineering or equivalent experience is preferred
- ISO 13485 Lead Auditor Certification is preferred.
- Significant experience in managing all aspects of Quality and Regulatory Compliance in an international, global or regional (Asia Pacific) context, in a regulated healthcare environment is required. Detailed knowledge of medical devices regulatory requirements and Experience in the medical devices or pharmaceutical industry is preferred. A demonstrated track record of achieving successful compliance and supporting regulatory agency inspections is required. Minimum 8 years of experience in Quality Assurance, Regulatory Affairs and/or Compliance is expected, including experience in performing GxP, GMP audits / support of medical devices manufacturing sites. Experience in working with regulatory agencies is preferred, especially with those in India / Asia Pacific.Experience in Quality Control and/or knowledge of Analytical and Micro lab and Stability testing programs will be an advantage.
- Proven ability to initiate and implement Quality System changes as a result of Compliance
- drivers. Strong project management skills and compliance mindset.
- Experience in interpreting regulatory requirements in the light of current guidance and international regulatory body field activity is preferred
- Experience in managing multiple projects, prioritizing and adapting to business needs and understanding of business requirements is expected.
- Experience in managing a team of direct reports, coaching and development is required.
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Others
- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community, plant and supply chain management, external regulators, and industry. Experience/ Credibility with external regulatory agencies would be an added advantage.
- Must have strong collaboration and influence management skills to partner effectively with plant leaders and quality heads. Proven track record of demonstrating collaboration across the organization and at all levels.
- Technical understanding of products and processes combined with business and compliance acumen.
- Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change.
- High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
- Financial, moral, personal integrity and the values that inspire trust in the organization.
- Must be able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas.
- Ability to stand firm while being open to new approaches.
- Ability to build partnerships both internally and externally. Makes the customer central to all thinking.
- Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve supply chain/ compliance stakeholder support for proactive and reactive measures.
Additional Information:
Location: Asia Pacific
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Compliance
Job Code: 1700184131W
End Date: 19th October, 2017
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