Senior Manager Regulatory Compliance

6942-ABIOMED Legal Entity • Cherry Hill, NJ

1d • Hybrid

About The Position

The position of Senior Regulatory Compliance Manager is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites 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 be a member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated Abiomed sites 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.

Requirements

• A minimum of a Bachelor’s degree in science or quality engineering discipline is required.
• A minimum of 8 years of related experience including 2-3 years’ specific experience in a management/supervisory role.
• Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry.
• 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
• Ability to recognize, build support for change and engage in constructive conflict.
• High tolerance for ambiguity in a complex environment
• Ability to make the complex clear and easily understood by others
• Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas
• Ability to build partnerships both internally and externally
• Capacity to put 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

Nice To Haves

• Current certification of quality system auditor or lead auditor is preferred.

Responsibilities

• Lead and manage site audit readiness activities to always ensure inspection readiness
• Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.
• Responsible for effective regulatory agency inspections.
• Audit preparation activities (auditor logistics, front room/back-room arrangements, identifying/preparing SME’s, etc.).
• Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site
• Schedule and manage mock inspections as part of External Inspection Readiness activities.
• Provide timely information to support the inspection process, including those that may be taking place at other sites / locations.
• Provide daily inspection communications regarding potential non-conformities.
• Prepare responses to any external inspection or other regulatory notification associated with site.
• Ensure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners and perform effectiveness monitoring and closure.
• Establish and execute an effective internal audit schedule for site
• Execute against established internal audit procedures
• Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
• Drive compliance and improvement in internal audit metrics
• Ensure quality system is periodically evaluated and audited and appropriate preventive/corrective action is taken to meet the business and regulatory requirements
• Where appropriate, execute program(s) for training and evaluating qualifications of auditors.
• Participate in JJRC audits as requested.
• Where appropriate assure representation on all required business unit, sector, and/or enterprise teams
• Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards.
• Connect and collaborate with other compliance teams
• Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
• Drive compliance to Quality and Compliance metric targets.
• Create reports and communicate performance against metrics to key stakeholders.
• Highlight/communicate adverse trends in metrics and take risk-based action to remediate.
• Assure that required compliance-related events (e.g., field actions, inspections) are entered in CURVE or equivalent systems per required timeframes.
• Assure that information in the above system is current and updated in a timely manner.
• Escalate items in accordance with established procedures.
• Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.
• Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
• Proactively assess and influence the external environment by participating on industry and regulatory body work teams.
• As appropriate collect and provide site input.
• Communicate outcomes and trends to key stakeholders.
• Support implementation of new external standards/regulations
• Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings
• Provide input into Quality System Management Reviews (e.g. internal audits) to allow meaningful review their tasks
• Proactively communicate organizational and compliance procedure/ policy related changes that may impact sites.
• Ensure feedback and alignment with said changes.
• Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, Manufacturing.
• Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
• As appropriate, perform annual performance appraisals for identified associates.
• Establish objectives and development plans for direct reports
• Support and promote the safety and environmental objectives of the facility

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior