Lead - Quality System & Compliance

Lead Quality System And Compliance I CTC: 30-35 lakh

Location- Aurangabad, Maharashtra

Job description

Experience: 8-10 years

Reporting to the Director -- Regulatory Compliance, the candidate will be responsible for establishing and maintaining a robust Compliance Program for a group of franchises (Ethicon & ASP) or region (Asia) in order to ensure compliance to local, national and international regulatory standards, company policies and procedures. He / she will be a member of the MD&D Regulatory Compliance team and will work closely with Franchise Compliance and Quality Operations leads.

Incumbent in this position is expected to provide strong coordination, including the development and implementation of internal and external audit schedules and resource allocation.

Lead-QS&C will also be responsible for coordination and deployment of sector policies and standards across all sites within the region.

Illustrative Responsibilities

Compliance Framework and Expertise

Establish and maintain robust compliance program. Ensuring compliance to local, national and international regulatory standards, company policies and procedures

- Partner with Enterprise, Sector and Franchise Compliance teams in order to coordinate the implementation of internal and external audit schedules

- Ensure qualified personnel, including knowledge, experience, and independence, performs the audits as per schedule

- Establish and maintain regulatory inspection readiness plan at each manufacturing site within the region in preparation for any regulatory inspection (internal and external). Supports manufacturing site regulatory inspections as required

- Partnership with Franchise Compliance team on the formulation of responses to regulatory agencies in order to address manufacturing related observations. Collaborate with other business 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 Franchise 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

- Alert management of product quality issues for proper and timely escalation to Material Review Board (MRB)

- Manage the relationship and contract with the notified bodies from a compliance perspective

- 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 MD&D Regulatory Compliance policies, practices, metrics and resources across the sector

- Maintain the region compliance dashboard for on-time Management reporting

- 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 within the region

- Provide input to the Franchise Compliance lead on the classification of severity of all Field Actions at all sites within the region

- Coordinate in conjunction with Quality Operations manufacturing plant-related recall activities as required

- Coordinate compliance training as required

- Monitor EDGE Database for Field Action, Regulatory Inspection and QScan data accuracy and completeness

Score manufacturing sites within the region as per QScan scoring schedule

- Supervise 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 Health and Safety requirements

- Manage compliance budget

Regulatory Intelligence

- Support an MD&D framework and 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 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

Other Responsibilities

- Ensure safe working conditions and practices in QA department.

- Develop, implement and support the facilities regulatory strategy.

- Support Corporate Quality Advancement Strategies.

- Provide support and guidance to key individuals and teams to assure compliance with minimum impact to the organization.

- Report Quality system and Compliance Scorecard results to the Plant QA Manager.

- Review and disposition document changes within areas of expertise per applicable procedures.

- Perform other work related duties as assigned by the Plant QA Manager.

Quality, Regulatory & Compliance (QRC) Responsibilities

Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware.

- Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines.

- Follow Bio-Safety practices while handling complaint samples and while working in the field. (Applicable for Sales & Marketing personnel and QA personnel).

- Use product samples, demo units when issued; for the designated purpose only.

- Report any evidence of product tampering, diversion and counterfeiting to the Brand Integrity function (Applicable for Sales & Marketing, Supply Chain and QA personnel)

- Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner (Applicable for Sales & Marketing, Supply Chain, RA, QA, Legal, Corporate Communication personnel).

- Promotional materials used in the field are duly approved through the Copy Review process (Applicable for marketing personnel).

Experience and Attributes

8 to 10 years of experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment is required. Detailed knowledge of the local India Pharmaceutical Regulations (Drugs & Cosmetics Act, Schedule M) and medical devices regulatory requirements is necessary. Experience in the medical devices or pharmaceutical industry is necessary. Possess a demonstrated track record of achieving successful compliance.

Proven success in:

- Working within a direct and indirect organization that delivers results.

- Building interdependent 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.

- Compliance experience and reputation, large-scale QMS experience.

- Strong analytical skills and experience implementing risk-based oversight programs across multiple sites or Corporate experience.

- Change management and project management experience.

- Strong executive presentation skills.

- Issue remediation experience.

- Collaborative approach.

- Managing complexity

- Bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level and attention to details.

Personal Attributes

- Requires 7-8 years related experience including 6-7 years specific experience in a management/supervisory role.

- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry.

- Must have strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units. Proven track record of demonstrating collaboration across the organization and at all levels.

- Balanced technical understanding of products and processes combined with superior 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. 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.

- 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 executive management support for proactive and reactive measures. Preferable

Requirements

- Post Graduate / Graduate degree in pharmacy or science required.

- ISO Lead Auditor or Lead Assessor Certification, preferred.

- Expertise on the local India Pharmaceutical Regulations (Drugs & Cosmetics Act, Schedule M) and ISO Standards, with the ability to apply these to real manufacturing issues.

Proven ability to initiate and implement Quality System changes.

- Strong Project management skills.

- At least eight (8) years of experience in local India Pharmaceutical Regulations

- Experience in the QSR/ISO-regulated medical device operation.

Desired Skills and Experience

Regulatory Compliance, QA Quality, Healthcare, Medical Devices, Qsr, Regulatory Requirements, Regulatory, Inspection, Auditing, Audits Pharmaceutical,Quality System Inspections, Quality Operations, Medical Device, Product Quality, External Auditing, Corporate Quality