Johnson Johnson Private Limited Looking for Senior Manager Regulatory Compliance at Aurangabad Full Time

Job Description

The position of the Senior Regulatory Compliance Manager is also referenced as Regional Compliance Manager since it is responsible for establishing and maintaining robust Compliance Programs at all the Ethicon sites within the region in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. The Senior Regulatory Compliance Manager will work with the Regulatory Compliance Leaders of all the Ethicon sites within Asia Pacific to accomplish such responsibilities.

The Senior Regulatory Compliance Manager will be a member of the Ethicon and J&J Regulatory Compliance (Asia Pacific) teams, will work with Quality Operations leads of all the Ethicon sites within the region and with the Regulatory Compliance teams of other regions and business groups.

The Senior Regulatory Compliance Manager is expected to collaborate with other groups within the J&J Regulatory Compliance (JJRC) organization to support execution of independent audits and special assessments, and deploy compliance initiatives.

The Senior Regulatory Compliance Manager is responsible for the deployment of J&J Quality System Standards across all sites within the region.

DUTIES & RESPONSIBILITIES*

The Senior Regulatory Compliance Manager will have following responsibilities:

Compliance Program

• Establish and maintain robust Compliance Programs at all the Ethicon sites within the region to ensure compliance to local, national and international regulatory requirements, company policies and procedures, and J&J Corporate requirements. This will be accomplished working with the Regulatory Compliance Leaders of all the Ethicon sites within the region.
• Partner with the Regulatory Compliance teams of other regions and business groups to support execution of internal audit schedules.
• Collaborate with other groups in the JJRC organization to support execution of independent audits and special assessments and deploy compliance initiatives.
• Ensure qualified personnel, including knowledge, experience, and independence, performs internal audits.
• Establish and maintain external audit/regulatory inspection readiness plans at all the Ethicon sites within the region in preparation for any external audit / inspection. Supports external audits / inspections e.g. Regulatory Agency, Health Authority, Notified Body; of the sites within the region as required.
• Partner with the appropriate Leadership and Regulatory Compliance teams on the formulation of responses to external audit observations related to all the Ethicon sites within the region. Collaborate with business partners in the identification and implementation of corrections, corrective and preventive actions. Ensure effective and timely completion of all actions.
• Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the Franchise quality system and its compliance to applicable regulations and standards. Ensure results of monitoring process are routinely communicated to management through the Management Review process.
• Alert management of quality and compliance issues for proper and timely escalation and resolution.
• Assure all external auditing companies meet internal requirements prior to executing any portions of the contracting agreement.
• Serve as a subject matter expert, as needed, to support proactive or reactive responses to issues.
• 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 Regulatory Compliance policies, practices, metrics and resources across the region.
• Ensure timely and accurate reporting and publishing of internal and external audit metrics for all the Ethicon sites within the region.
• Provide input on the classification of all External Audits (i.e. Regulatory Agency/Health Authority inspections, Notified Body audits) and observations for all the Ethicon sites within the region.
• Coordinate compliance training as required.
• Monitor internal databases such as CURVE Database for Field Action, Regulatory Inspection and QScan data accuracy and completeness.
• Score manufacturing sites within the region as per QScan scoring schedule.
• Supervise regulatory compliance personnel according to Human Resources policies and procedures, including hiring, training, and mid/end-year performance appraisals.
• Provide leadership and development to all direct reports assuring active participation in performance management, succession planning and talent development activities.
• Ensure all direct reports comply with Environmental, Health and Safety requirements.
• Manage compliance budgets for all the Ethicon sites within the region.

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 approaches.
• Work with other Regulatory Compliance teams to identify, prioritize and ensure implementation of new and revised regulatory requirements and expectations.
• Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings. Support implementation plans for regulatory changes including routinely monitoring and verification of implementation activities.

Other Responsibilities:

• Support Quality and Compliance Strategies.
• Provide support and guidance to key individuals and teams to assure compliance with minimum impact to the organization.
• Ensure alerting, reporting and escalation of Quality and Compliance issues to the appropriate Leadership and Regulatory Compliance teams.
• Perform other work-related duties as assigned by the Director, Regulatory Compliance.

EXPERIENCE AND EDUCATION*

• Degree or Post graduate degree in Science, Pharmacy or Engineering or related field is required
• At least seven (7) years of experience in the ISO 13485/Health Authority-regulated industry (medical devices or pharmaceuticals/Health Care), including at least five (5) years of experience in Quality Assurance or Regulatory Compliance functions and management roles.
• Detailed knowledge of medical devices regulatory requirements of the region is necessary.
• Experience in performing GxP / GMP audits and/or support of medical devices manufacturing sites is required.
• Experience in managing multiple aspects of Regulatory Compliance in an international/global context and a regulated healthcare environment.
• Experience in implementing regulatory requirements /regulatory changes such as Medical Device Regulations in a manufacturing set-up, to ensure Compliance, will be an advantage

Proven experience and success in:

• Working within a direct and indirect organization that delivers results.
• Building partnerships, acting as the mediator between operating units while optimizing the value proposition.
• Building consensus and impacting outcomes without always having line authority; able to negotiate trade-off decisions across the organization.
• Implementing risk-based oversight programs across multiple sites or Corporate experience.
• Change/project management
• Initiate and implement Quality System changes.
• Issue remediation.
• Use of collaborative approach.
• Managing complexity.
• Use bifocal approach – ability to zoom-in/zoom-out for strategic and tactical, high-level and attention to details.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENCES and AFFILIATIONS*

• Lead Auditor Certification is preferred.
• Must have experience in manufacturing site environment (in Quality, Regulatory Compliance or Operations).
• Expertise on/detailed knowledge of regulatory requirements in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical/consumer goods), with the ability to relate them to business/quality issues.
• Excellent written and oral communication skills, ability to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry. Strong presentation skills.
• Strong collaboration and influence skills to partner effectively with other functions and across Operating Units. Proven track record of demonstrating collaboration across the organization and at all levels.
• Strong analytical skills. Balanced technical understanding of products and processes combined with superior business and compliance acumen.
• Ability to make decisions which will effectively support the business and company policies.
• Strong change/project management skills.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict.
• 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.
• Ability 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 executive management support for proactive and reactive measures.
• Capacity to put the customer central to all thinking.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

• Directly and indirectly manages the site regulatory compliance organization within the region. This position is responsible for all performance management activities of direct reports including goal setting, development planning, performance appraisals and compensation planning.
• Reports to the Director, Regulatory Compliance (Ethicon).
• Encounters internal interface/interactions required for the duties and responsibilities defined in the previous sections of this Job Description.

LOCATION & TRAVEL REQUIREMENTS

Location Aurangabad – India – with requirement of 20-30% travel, with peaks depending on issues.