Senior Manager Source Compliance

Johnson & Johnson Innovative Medicine•Boston, MA

1d•$127,000 - $218,500

About The Position

This position provides Worldwide Source Compliance leadership in developing, implementing, and continually improving Source Compliance programs for suppliers, including external manufacturers and direct and indirect suppliers. The role ensures post-audit activities are completed according to established procedures, including Supplier Audit Response support and alignment, supplier action-plan follow-up and closure, external-manufacturer follow-ups, metric reporting, and ongoing process improvement. It partners with business functions, supplier quality and supplier relations teams, and suppliers, and supports external audits and inspections at business sites and suppliers as needed. The role establishes and executes supplier compliance strategies, oversees supplier remediation programs, provides compliance data and analytics, and communicates supplier-related regulatory developments and Health Authority inspection outcomes to the business. It leads Source Compliance input to executive management reviews, manages the assigned budget, and recruits, develops, and manages direct reports and contractors. The position also supports external Health Authority and notified-body responses concerning supplier and purchasing-control observations.

Requirements

Bachelor’s degree in Business, the sciences, or Engineering.
At least 8 years of combined experience in Regulatory Compliance and/or Quality for medical devices or pharmaceutical products.
Strong knowledge of FDA and global medical-device regulations and standards such as ISO 13485.
Experience executing investigations and developing corrective actions.
Experience managing professional associates.
Experience working with suppliers.
Ability to engage senior management in identifying critical needs and ensuring effective deployment across the sector.
Demonstrated ability to work remotely and partner globally.
Ability to foster an effective multifunctional, cross-region, cross-company team environment.
Strong written and verbal communication skills.
Strong leadership, partnering, influence, negotiation, and change-management skills.
People leadership, project management, problem-solving, investigation, and presentation skills.

Nice To Haves

Master’s degree or another advanced degree.
Medical-device experience.
Experience actively participating in external inspections.
Auditing experience, especially supplier auditing.
Auditor certification.

Responsibilities

Establish, manage, maintain, and continuously improve Source Regulatory Compliance activities for assigned business suppliers.
Work with suppliers on Supplier Audit Responses and align on second-pass responses.
Track supplier audit observations through completion and execute follow-ups for external manufacturers.
Analyze data, report metrics, and work with suppliers and internal observation owners to achieve Green supplier audit metrics.
Prepare Source Compliance presentation slides.
Partner with ERC auditors, SPOCs, Quality, and Supplier Relations to establish and maintain supplier relationships and supplies.
Establish and execute compliance strategies for supplier management.
Recruit, develop, and manage direct reports and contractors.
Support external audits and inspections at sites and suppliers as required.
Lead Source Compliance input to executive management reviews for the assigned business.
Support development and review of external Health Authority and notified-body responses concerning supplier or purchasing-control observations.
Provide business partners with periodic compliance data, analytics, and current global Health Authority trends; develop proactive approaches to regulatory trends.
Oversee and conduct compliance reviews of supplier remediation programs.
Lead or contribute to strategic Source Regulatory Compliance initiatives and projects.
Inform the business about new supplier-related Health Authority regulations, changing expectations, and Health Authority inspection results.
Establish and manage the assigned Source Compliance budget.
Communicate business-related issues or opportunities to the next management level.
Follow applicable Company Health, Safety, and Environmental guidelines and ensure that managed staff follow them and have needed resources, as applicable.
Ensure personal and Company compliance with applicable federal, state, local, and Company regulations, policies, and procedures.
Perform other duties as assigned.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year, with different allowances for employees residing in Colorado or Washington, subject to policy and hire date.
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 a child’s birth, adoption, or foster-care placement.
Bereavement leave: up to 240 hours for an immediate family member and 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.