Director, Commercial Quality - Americas

Johnson & Johnson•Cherry Hill, NJ

3d•Onsite

About The Position

The individual will lead the Commercial Quality function focused on compliance for Americas commercial operations, field action execution, Commercial and 3PL logistics supplier quality, and supplier quality management for distributors. The incumbent will recommend and drive implementation of compliant, fit for purpose controls on these activities, with an unwavering focus on customer experience. This role is based in Danvers, MA.

Requirements

Undergraduate degree in science, engineering, or a related scientific field.
Specific quality, regulatory and regulatory compliance competencies in the areas of commercial quality, supplier quality, distribution and customer service.
Experience in positions of growing responsibility supporting large, multi-site, global organizations, with broadly based quality management experience.
Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements.
Previous experience working with global regulatory agencies, e.g., US FDA, Health Canada, COFEPRIS, ANVISA supporting higher risk product classifications.
Builds consensus and impacts outcome without always having line authority and can achieve trade off decisions across the organization.
Decisive, organized, and able to lead people within a complex global environment.
Excellent communication / presentation skills, able to inspire trust and quickly build credibility within the Quality & Compliance and Commercial organizations.
"Hands-on" orientation focused on the customer.
Accountability, with a desire to commit, and be rewarded for delivering results.
Recognizes and builds support for change.
High tolerance for ambiguity in a complex environment.
Makes the complex clear and easily understood by others.
Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally.
Engages in open and honest communications.
Fluent in English.

Nice To Haves

Master’s degree in business, science, engineering, or a related scientific field.
Strong collaboration and influence leadership skills to partner optimally 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.
Additional LATAM language capability is a plus.

Responsibilities

Partners with the Abiomed Americas Commercial and Customer Service organizations to define customer priorities and quality plans to achieve customer requirements, and support growth and market expansion.
Implements aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations supporting the growth forecast for the Abiomed business.
Supports the Americas Commercial organizations and leadership teams as the key Quality partner to resolve quality related issues and guide business decision making through a quality lens.
Responsible for all Quality lifecycle aspects of the distributor network in the Americas including qualification, audit, Quality Agreement and disengagement.
Supports distributor compliance through negotiation, relationship management and enforcement of regulations and quality agreement requirements.
Owns the field action process execution oversight responsibility for the Americas region including correction implementation reporting.
Responsible for customer/distributor field action communications outside of the United States.
Interacts directly with government health authorities and notified bodies in support of audit and field action execution, inclusive of US FDA, Health Canada, ANVISA, COFEPRIS and others.
Support Quality responsibilities including SOP approval, Change Control and CAPA/Non-Conformance management for Customer Service, Commercial Operations, Clinical Sales Training, Medical Affairs, Marketing and Platform Operations and others as required.
Responsible for the Commercial Supplier Quality management program within the Americas region, inclusive of suppliers for marketing and promotional materials, transportation, and field action support.
Connects the Abiomed organization to the broader J&J Quality and Compliance organizations to identify efficiency opportunities, SME knowledge, standard methodologies, and cost improvement opportunities.
Ensures appropriate personnel training is planned and achieved to support compliant operations within commercial quality.
Other activities as required by management.

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
Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Eligible to participate in the Company’s long-term incentive program.