Position Title : Sr. Director, Abiomed Supply Chain Quality
Supervisor Title : VP, Q&C J&J MedTech Abiomed
Physical Location of Position: Danvers, MA
Geographic Scope of Responsibility: Global
This position reports to VP, Q&C Abiomed and is part of the Q&C Abiomed leadership team.
This role is responsible for the Abiomed Supply Chain Quality Operations, processes and systems associated with the internal manufacturing sites (Danvers, Woburn, Aachen, Berlin, Baltimore, & Japan) as well as the external suppliers; Indirect, Direct, and External Mfg. In addition this role will play an instrumental role leading Abiomed Q&C supply chain transformation, orchestrating all the elements of the Abiomed Q&C organization in collaboration with, platform teams, Commercial teams, R&D and Supply Chain to co-create and execute a Quality operational strategy.
Responsible for driving End to End Supply Chain Quality Execution governance, synergies and optimization across the global network including development and execution of Operational Excellence Strategy across all sites within the platforms. This role will have overall management responsibilities for both financial and talent including planning for current and future business needs.
In addition, the incumbent will develop and execute supplier capability improvement program, working with the MD Supply Chain COE leaders to ensure initiatives are identified, resourced, completed and measured. He/she will gather data insights and proactive risk measures to identify areas of concern and leverage/execute capability tools/programs to proactively mitigate risk areas to improve Supplier Reliability.
The Abiomed Supply Chain Quality Sr. is responsible for Quality Performance of the Abiomed Global supply chain, including all internal and external manufacturing sites globally.
This role will also lead the team to drive integration programs and lead value-based continuous improvement across Abiomed Q&C community.
Major Duties/Responsibilities (80%)
Strategy Development, Operationalization and Performance Management
1. Oversees the quality activities for Abiomed manufacturing facilities. Establishes one Quality Leader with receiving to shipping dock “accountability” including but not limited to; Supply Chain Continuity, Finished Good Product Release, Compliance Readiness Activities, Inspection Execution, Quality System Execution (NC/CAPA/CAPs) and Quality Engineering.
2. Partner with Supply Chain to effectively develop and deploy the Supply Chain & Quality strategic plans and assure the integration/alignment of the quality operations strategy at the business level
3. Establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards.
4. Ensures plant(s) assess QS effectively through internal audit and Management review and implement corrective/ preventive, improvement actions as appropriate.
5. Oversight and responsibility for complete and correct manufacturing related complaints investigations. Ensures customer feedback and complaints are address in appropriate and timely manner.
6. Executes responses to field actions and coordinates global response with the franchise Quality leadership and corporate functions.
7. Champions a Patient First Quality culture sustained by the systemic implementation of Lean Strategies to Quality Business processes to drive Continuous Improvement and Compliance, while delivering Value Enhancing solutions.
8. This individual has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.
9. Establishes and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business.
Additional duties (20%):
Drive integration & technology programs and lead value-based continuous improvement across Abiomed Q&C community.
1. Lead technology transformation such as Automated Product Release including strategy development, roadmap planning, governance, and change management
2. Lead continuous improvement on targeted business processes such as Testing / Inspection & Release (including Labs), Process Validation & Qualification, Certificate of Analysis, Production / In-process Controls, Rework/Reprocessing, Manufacturing environmental controls, and Stop Shipment
3. Advance key organizational capabilities such as analytics & insights, digital dexterity, business acumen, and qualitative skills in support of transformation and continuous improvement focus areas
4. Cultivate and manage stakeholder relationships with Abiomed Q&C peers, Abiomed LT Leaders, and QS COE pillar LT members to drive strategic alignment and prioritization of resources
5. Direct and resource Q&C DPS team to successfully deliver against agreed upon priorities with outcomes realized in the franchises
6. Connect cross-sector / cross-function / externally identify and leverage disruptive technologies that benefit Abiomed Q&C
Required Minimum Education: Bachelor's Degree required.
Required Years of Related Experience: 10+
Required Knowledge, Skills and Abilities:
§ A visionary, strategic thinker with superior capability to bring clarity to complex concepts and to mobilize and align the organization to deliver on the strategy and translate strategy into financial forecasts and business plans
§ Quality & Compliance professional with 15+ years of relevant experience in medical devices, pharmaceutical industry, preferably 5-10 years in Quality leadership roles, with experience in other functions roles such as manufacturing, supply chain, R&D, Commercial.
§ Deep knowledge of medical device industry and MD regulations.
§ Demonstrated leadership capability leading large and complex culture transformation
§ Demonstrated business acumen being able to connect business E2E with QMS requirements.
§ Demonstrated knowledge of and compliance with applicable Quality System requirements (i.e. QSRs, ISO) is required
§ Strong project management and influencing skills required
§ Strong written and verbal communication skills to communicate effectively at all levels (internal and external) is required
§ Proven success in applying innovative approaches to Quality Management solutions and applications in a fast-paced changing business environment preferred
§ Ability to drive timely decisions with sometimes minimal data is required
§ Quality Management, supervisory and people development skills are required.
§ Ability to analyze strategic investments to make effective trade-off recommendations, balancing risk while leading through change.
§ Excellent communication skills and the ability to interface effectively with all levels of the organization
§ Executive presentation skills are required
§ Build interdependent partnerships, and internal and external relationships
§ Strong blend of tactical and strategic management skills.
§ Up to 30% domestic and global travel
§ 5 years of people management experience
Preferred Minimum Education: Post-Graduate Degree (Masters)
Preferred Area of Study: Engineering or Technical/Science
Preferred Related Industry Experience: A minimum of 10 years’ experience working in a quality, manufacturing and or project management in the Medical Device or other regulated industry.
Preferred Knowledge, Skills and Abilities :
§ Experience in Supply Chain, Commercial, and/or R&D, associated with customer experience journey
§ Experience with Six Sigma/Process Excellence tools, training and certification is preferred.
§ Experience with ideation events and/or in innovation methodologies (ex = Design Thinking, Agile, Lean etc.)
§ Organizational change management experience is preferred
§ Project Management experience, to include resource management, FTE demand, risk analysis, cost optimization