Senior Manager Of Quality Systems

Description

Ethicon is recruiting for a Senior Manager of Quality Systems, primary location in Raritan, NJ. This position can also be based at any other Ethicon location in North America, Puerto Rico, Mexico or Brazil.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

This position will have responsibility for the end-to-end process related to product quality issue investigations through the decision-making framework of risk management, quality review boards and field action execution while incorporating worldwide standards and regulations. Additionally, the position will have responsibilities for identifying improvement trends to present opportunities to top management and direct report supervision, performance and development planning for the team

Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:

• Drive operational excellence of product investigations and field action processes under applicable J&J procedures and regulatory requirements.
• Manage Ethicon teams responsible for scheduling, coordination and preparation of Product Issue Escalation and Quality Review Board (QRB) Meetings.
• Oversight of the department’s budget, hiring, retaining and developing qualified personnel, as well as resolving all personnel issues and employee performance management.
• Provide support to internal and external audit processes. Serve as SME in responsible areas for internal and external audits.
• Monitor key process metrics for product issue investigation and field actions, communicate status and find opportunities for process improvements across MedTech organizations.
• Support OUS affiliates, with monitoring of field action reporting through action closure, identifying process improvements to ensure timeliness closures.
• Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR) as well as all other applicable global regulatory requirements.
• Act as a representative for J&J Medical Devices to US FDA, worldwide health authorities and notified bodies, as applicable.
• Communicate business-related issues or opportunities to next management level.
• Lead field corrective actions, any associated regulatory actions and follow-ups; lead in product problem resolution as part of follow-up from QRB and CAPA.
• Supervise technology platform supporting the product issue investigation, quality review board, and field action processes to ensure compliance to regulations and standards and effective internal process flow.
• Participates and stays well-informed of enterprise solutions and their impact to emerging field action and product quality issue internal and external standard changes.
• Establishes and maintains training programs to implement field actions with required partners to effectively determine product quality issue resolution.
• Responsible for communicating business related issues or opportunities to next management level.
• For those who supervise or lead staff, responsible for ensuring that subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
• Additional responsibilities as assigned and needed.

Qualifications

Education:

• University/Bachelors degree or equivalent in Scientific and/or Engineering field.

Experience and Skills:

Required:

• Minimum of eight (8) years of related work experience.
• At least five (5) years of related experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry.
• Previous supervisory/people management experience.

Preferred:

• Experience working with FDA Quality System Regulation and ISO 13485 Standard.
• Experience in Quality Systems.
• Ability to interpret and apply regulatory requirements and industry standard methodologies [e.g. Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR)].
• Leadership skills with demonstrated ability to effectively train, mentor, and influence a diverse array of employees at all levels of the organization.
• Ability to influence teams and partners to ensure consistent and appropriate decisions are made and properly documented within the Quality System.
• Excellent interpersonal and influencing skills. Strong oral and written communications skills with ability to speak to broad, non-technical audiences that are both internal and external personnel. Skilled at preparing executive briefings and broad communications.
• Experience with preparing and reviewing technical documentation.
• Ability to prepare and perform audit reviews of Quality system documentation for compliance readiness.
• Ability to work in fast paced environment and rapidly shifting priorities.
• Experience working with product risk management and applying analytical and problem-solving skills.
• Experience leading geographically dispersed teams.

Other:

• The anticipated base pay range for this position is $118,000 to $203,550.
• The anticipated base pay range for this position is, in the Bay Area, is $136,000 to $234,140.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to:

• https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on 5/24/2024 . The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.