Senior Director Quality, Medtech Strategic Programs

Job Description - Senior Director Quality, MedTech Strategic Programs (2406176757W)

Senior Director Quality, MedTech Strategic Programs - 2406176757W

Description

Ethicon Inc. is recruiting for a Senior Director Quality, MedTech Strategic Programs to be located in Raynham, MA, San Angelo, TX, Jacksonville, FL, Palm Beach Gardens, FL, Irvine, CA, Guaynabo, PR, Añasco, PR, Costa Rica, Brazil, or Juarez, MX. This a 3 year duration-based role.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

The Sr. Director, Strategic Programs will lead Med Tech Quality and Compliance strategies associated to the start-up of the new Med Tech Manufacturing facility in Costa Rica.The Sr. Director, Strategic Programs will engage with business partners including Supply Chain, Regulatory, R&D, Finance, Engineering Services, and multiple Quality functions across different Med Tech Franchises, to ensure that all manufacturing processes, systems, and people capabilities are ready to manufacture products at the highest quality standards from inception. The Sr. Director Strategic Programs will be responsible for developing and implementing robust quality control programs, driving continuous improvement initiatives, and establishing quality assurance practices that align with industry best practices and applicable regulatory requirements.

Key Responsibilities:

Quality Start Up Strategy Development

· Develop a comprehensive quality strategy for manufacturing start-up operations, in alignment with organizational goals and objectives.

· Design Quality Management System Strategy for the site and applicable project plan.

· Define quality objectives, establish quality metrics, and develop plans to ensure adherence to quality standards throughout the start-up process. –

· Collaborate with cross-functional teams to integrate quality requirements into the manufacturing processes, including facility design, equipment selection, and workflow optimization.

· Develop and execute quality governance in collaboration with Franchises in scope, Regulatory Compliance, Sterilization Teams, R&D Quality, JJT and Med Tech Quality Centers of Excellence.

· Define Quality & Compliance Communication and Change Management in alignment with project phases.

· Partner with Quality & Compliance Functions in the determination and securing of Quality Resources.

· Establish Transfer Quality Plans and relevant Project Strategies, translate requirements into project cost/schedule/resource implications.

· Assess project interdependencies with other Quality & Compliance initiatives.

· Serve as Single Point of Contact for end-to-end Quality related matters.Provide Technical Leadership in Quality & Compliance Relevant Areas.

· Define quality objectives, establish quality metrics, and develop plans to ensure adherence to quality standards throughout the start-up process.

· Input impact to Quality & Compliance Long Range Financial Planning (LRFP) and Quality & Compliance Financial Business Planning (FBP).

· Lead and/or influence Capital Appropriation Request processes in alignment with the overall Quality strategy.

· Develop site regulatory certification strategy in collaboration with JJRC and Regulatory.

· Partner with Procurement and Source Quality teams to develop Suppliers Qualification strategy.

Cross Franchise Project Execution and Results Monitoring

· Responsible for Project Management aspects of quality functions within the overall Project Management structure.

· Liaise with relevant Quality & Compliance Functions across different Franchises to address project quality aspects.

· Lead escalation, investigation and corrective actions for significant Quality Issues reported during the execution of the program.

· Manage Quality Resources assigned to the project.

· Maintain Quality & Compliance Stakeholders updated of relevant aspects oof the project.

· PMO Updates and Reporting (financial, schedule, Quality & Compliance KPIs, etc.).

· Maintenance, escalation, and resolution of Network-related PMO Actions relevant to Quality.

· Serve as S&D single point of contact (SPOC) on Med Tech Franchises/Quality leadership teams as applicable.

· Set targets for key performance indicators (KPIs) and implement regular monitoring and review mechanisms.

Capabilities Development

· Design Quality organizational structure in support to aligned operating model and QMS requirements.

· Develop staffing plans for various leadership roles in collaboration with all applicable Quality functions.

· Develop knowledge transfer and talent hiring strategy for Quality related processes and operations in collaboration with applicable Med Tech Franchises.

· Develop onboarding programs and training plans to ensure staff are prepared for their roles and responsibilities.

· Develop Inspection and Testing Strategy (Analytical/Functional/Micro Labs and Receiving Inspection in collaboration with applicable Franchises including sourcing of equipment, qualification and validation, and compliance to J&J standards and external regulations.

· Ensure alignment of process and procedures to J&J Standards.

· Work with QSDS CoE and JJT to ensure timely development and implementation of the MS digital applications.

· Develop the foundational framework for a robust Quality Culture encompasses the collective mindset and behaviors of individuals within the organization towards achieving and maintaining high-quality standards.

· Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

· Develop Supply Chain Quality Process Transfer playbook to enable future site growth.

· Develops relationships with leaders to determine organization's needs and appropriate measures to make necessary changes.

· Directs Directors, Senior Managers, and occasionally senior individual contributors in a matrix environment, and is accountable for meaningful career development conversations and regular coaching and feedback.

Qualifications

Education:

· A bachelor’s degree is required

· Post-Graduate Degree in Quality/Regulatory, Business, Engineering, Science is preferred

Experience and Skills:

Required:

· A minimum of 12 years experience in a regulated environment and at least 7 years experience in Quality

· In-depth knowledge of quality and manufacturing systems and processes and applicable regulations, i.e. ISO 13485, FDA’s GMPs for medical devices.

· Front room leadership and/or complex regulatory compliance experiences, such as warning letter, consent decree or other recovery activities.

· Superior regulatory, technical and business knowledge to develop operational strategies for continued quality assurance.

· Ability to apply project management skills to ensure fulfillment of long-term requirements.

· Proven experience leading complex projects (Ex; Start-up, acquisitions/integrations)

· Experience in leading and motivating cross functional-teams, providing clear direction, and fostering a collaborative work environment.

· Proven ability to think critically and strategically, analyzing problems and developing innovative solutions to drive business objectives

Preferred:

· Experience in Medical Devices and Diagnostics

· In-depth knowledge of external operations and supplier quality management processes CQM, CQA or CQE Certification from the American Society for Quality (ASQ) or equivalent.

· Experience with Six Sigma/Process Excellence tools, training and certification is preferred.

· Project Management Certifications

· Bilingual (Spanish/English)

Other:

Over 50% travel is required

The anticipated base pay range for this position is $163,000 to 282,900.

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:

o Vacation – up to 120 hours per calendar year

o 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

o Holiday pay, including Floating Holidays – up to 13 days per calendar year

o Work, Personal and Family Time - up to 40 hours per calendar year

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

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 3/26/24.The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

This position is eligible for severance.

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.

Primary Location

Primary Location

NA-US-Massachusetts-Raynham

Other Locations

Other Locations

NA-US-Florida-Palm Beach Gardens, Latin America-Brazil, Latin America-Costa Rica, Latin America-Mexico-Chihuahua-Juarez, NA-US-Puerto Rico, NA-US-Florida-Jacksonville, NA-US-California-Irvine, NA-US-Texas-San Angelo, NA-United States, NA-US-Puerto Rico-Guaynabo, NA-US-Puerto Rico-Anasco

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement.

If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance

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