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Cork, IE

Quality Operations Compliance Senior Manager-00000892

Description

Role Profile

Quality Operations Compliance Senior Manager,

DePuy Synthes EU

Role Overview

The Quality Operations Compliance Senior Manager reports directly to the Director of Quality Operations Compliance.

The Quality Operations Compliance Senior Manager is responsible for establishing and maintaining a robust Compliance Program for the EU manufacturing sites within the DePuy Synthes Supply Chain in order to ensure compliance to local, national and international regulatory standards, company policies and procedures and J&J corporate requirements.

The Quality Operations Compliance Senior Manager will be a member of the MD&D Quality Operations Compliance Team and will work closely with DePuy Synthes Franchise Compliance and DePuy Synthes Quality Operations Cluster leads.

The Quality Operations Compliance Senior Manager is expected to provide strong coordination among Enterprise, Franchise and Sector Compliance teams, including the development and implementation of internal and external audit schedules and resource allocation.

The Quality Operations Compliance Senior Manager is responsible for coordination and deployment of sector policies and standards across the EU manufacturing sites within the DePuy Synthes Supply Chain.

Responsibilities

The Quality Operations Compliance Senior Manager will have following responsibilities:

Compliance Framework and Expertise
- Establish and maintain robust compliance program ensuring compliance to local, national and international regulatory standards, company policies and procedures, and J&J Corporate requirements.
- Partnership 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, perform the audits.
- Establish and maintain regulatory inspection readiness plan at each EU manufacturing site within the DePuy Supply Chain 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 sector 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 compliance policies, practices, metrics and resources across the sector.
- Maintain the cluster 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 EU DePuy Synthes Supply Chain manufacturing sites.
- Provide input to the Franchise Compliance lead on the classification of severity of all Field Actions at EU DePuy Synthes Supply Chain manufacturing sites.
- Monitor Field Actions at EU DePuy Synthes Supply Chain manufacturing sites and ensure adequate and timely implementation of corrective actions to address root cause(s) of manufacturing related issues.
- 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 EU DePuy Synthes Supply Chain manufacturing sites as per QScan scoring schedule.
- Supervise compliance and quality systems 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 departmental budget.
- Perform other work-related duties as assigned by the MD&D VP of Quality Operations.

Regulatory Intelligence
- Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
- 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.

Scope of Responsibilities
- Quality Compliance and Regulatory Intelligence across EU manufacturing sites within the DePuy Synthes Supply Chain.

Qualifications


Experience and Key competencies
- A minimum of a Bachelors degree is required in science, engineering, or equivalent is strongly preferred. Post Graduate Qualification in Quality / Regulatory preferred.
- A minimum of 10 years of relevant industry experience. A minimum of 5 years management experience in the Quality and Regulatory Compliance in the medical device/ pharmaceutical industry.
- Strong knowledge of quality and compliance in a regulated manufacturing environment (GMPs).
- Working knowledge of Quality System Regulations.
- Prior experience managing External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred.

- Experience in auditing to FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
- ISO Lead Auditor or Lead Assessor Certification, preferred.
- Demonstrated knowledge of business impact of compliance issues and risk management
- Demonstrated effective people management in multiple locations
- Experience in preparing for & managing external third party audits in multiple locations
- Proven ability to build partnerships both internally and externally
- Proven ability to initiate and implement Quality System changes.
- Background in Information Mapping and Process Mapping.
- Strong Project management skills.

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
- 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.

Location
- Location is at one of the EU manufacturing sites within the DePuy Synthes Supply Chain (Cork Ireland, LeLocle/ Neuchatel Switzerland, Blackpool/ Leeds UK) with requirement of 30-50% travel, with peaks depending on issues.

Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy (Ireland) Limited (7386)
Job Function: Quality (Eng)