FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior Director, Commercial Quality
Johnson & JohnsonSenior Director responsible for leading Commercial Quality initiatives and compliance at Abiomed, driving strategic integration with J&J. Overseeing global quality operations and team management across multiple regions.
About the role
Key responsibilities & impact- Models Johnson & Johnson Credo behaviors and decision making and ensures organizational compliance to the Johnson & Johnson Code of Business Conduct.
- Manages, develops, and motivates team using the J&J five conversations model.
- Identifies high potential talent, mentors, and advocates for that talent, and works proactively to accelerate development.
- Drives a proactive and accountable culture of Inclusion.
- Partners with the Abiomed Regulatory Affairs, Commercial and Distribution organizations to define customer priorities and quality plans to achieve customer requirements, support growth and ensure compliant commercial and distribution operations in all global markets.
- Defines in collaboration with the Operations and Quality representatives of Abiomed, processes, systems, resources, and SOPs, for the organization in line with the J&J policies, J&J standards, and applicable regulations.
- Owns operational responsibility for Abiomed Commercial Quality execution in the regions.
- Connects the Abiomed organization to the broader J&J Commercial Quality and Distribution organizations to identify leveraging opportunities, SME knowledge, best practices, and cost improvement opportunities.
- Drives a collaborative approach for integration of Abiomed into the J&J family.
- Accountable for ensuring compliant startup of new Peabody facility operations via execution of the quality plan, including inspection management during Health Authority visits and ERC or internal audits.
- Ensures necessary site licensing and certification activities are completed in cooperation with Regulatory Affairs, inclusive of US FDA registration, Notified Body certification and State Board for Pharmacy distribution license.
- Reviews construction plans and design documents to ensure compliance to requirements.
- Identifies outside support resources for qualification activities.
- Reviews, and approves (as applicable) new facility risk assessments and process qualification protocols, results, and final reports.
- Ensures a comprehensive suite of controls documents (SOP/WI) for the new facility is established, leveraging and improving upon existing documents from the Danvers site.
- Ensures appropriate personnel training is planned and achieved to support compliant operations at the new facility.
- Establishes programs to effectively monitor and assess the performance of the project quality plan through metrics, scorecards, and review with Abiomed Quality and Operations.
- Identifies resource needs to ensure project success.
Requirements
What you’ll need- Expert level technical knowledge in applicable regulations, quality systems and operations for medical device and/or pharmaceutical construction, qualification, manufacturing, commercial quality, and distribution activities including inbound material inspection, mix-up prevention, labeling and kitting, storage, and transportation.
- A motivated leader who is passionate about coaching and leading high performing teams; and has a strong record of accomplishment for successfully executing strategic initiatives through collaboration with key stakeholders to bring measurable and significant impact to the organization.
- Experience in positions of increasing responsibility supporting large, multi-site, global organizations, with broadly based quality management experience and extensive people management experience.
- Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements.
- Builds consensus and impacts outcome without always having line authority and can negotiate trade off decisions across the organization.
- Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
- Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed.
- Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.
- Undergraduate degree in science, engineering, or a related scientific discipline.
Benefits
Comp & perks- an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
- several insurance plans
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality ManagementRegulatory AffairsOperational ResponsibilityProcess QualificationInbound Material InspectionMix-Up PreventionLabeling And KittingStorage And TransportationConstruction Compliance ReviewPerformance Monitoring
Soft Skills
Coaching And LeadershipAnalytical SkillsStrategic ThinkingNegotiation SkillsConsensus Building
Certifications
US FDA RegistrationNotified Body CertificationState Board For Pharmacy Distribution License