Johnson & Johnson, Cardiovascular & Specialty Solutions (CSS) is recruiting for a Manager, Clinical / Preclinical Quality Cardiovascular Specialties & Solutions (CSS). This is a remote position but travel to the site in either Santa Rosa, CA or Irvine, CA is required.

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/.

Johnson & Johnson is seeking an experienced professional to lead clinical / preclinical quality oversight in support of the CSS MedTech business. The Manager, Clinical / Preclinical Quality Cardiovascular Specialties & Solutions (CSS) works to support the R&D Quality objective and strategy in leading all aspects of a robust GxP Quality Management System to enable a diverse portfolio of medical device products and services. This person will serve as the clinical / preclinical quality point of contact to support Licensing & Acquisition activities, integration, risk assessment, mitigations, remediation, inspections, and provide guidance on compliance-related activities within the business unit in GLP & GCP, ISO 14155:2020, as well as other applicable external regulations/ requirements, and internal JNJ procedures.

The Manager, Clinical / Preclinical Quality Cardiovascular Specialties & Solutions (CSS) is a subject matter authority and acts as a contact for Clinical and Preclinical Research & Development (R&D) functions, as well as other internal team members and business partners.

Key Responsibilities:

Lead Remediation & Integration

• The Manager, Clinical / Preclinical Quality Cardiovascular Specialties & Solutions (CSS) will plan and lead quality integration activities to ensure effective execution of new product development, lifecycle management, supplier management, while providing overall preclinical and clinical quality oversight. This leader is responsible for remediation and integration of quality system elements to relevant internal and external standards as required.
• The leader requires expertise in GLP, GCP regulations requirements (e.g., 21 CFR Part 58, ISO 14155:2020, 21 CFR Part 11, and 21 CFR 812).
• Partners with Clinical and Preclinical R&D and across other functions to define needs for standardization and to ensure compliance with standard operating procedures, applicable regulations, and standards. The leader supports new business development initiatives, including due diligences, post acquisition assessments/ audits as the need arises.
• Coordinates with Regulatory Compliance, Business Development, and the License & Acquisitions team to integrate newly acquired assets and companies into the base RDQ operating model.
• Owns CAPA/ Data Review Activities as applicable related to remediation / integration activities.

Portfolio Oversight

• Prepare and provide periodic updates on the state of the applicable QMS to R&D, R&D Quality, Franchise Quality, and Clinical Risk Management, including. Responsible for communicating business related issues or opportunities to management.
• Develop and lead proactive risk management strategies in coordination with Clinical and Preclinical R&D business partners.
• Proactively assess clinical and preclinical risks to the business and work with management to devise and implement policies and procedures to address and lead risk mitigation strategies including preventative actions, training, and communications.
• Ensure timely escalation of critical issues in compliance with internal requirements.
• As needed, forecasts headcount and resource needs.
• Support clinical and preclinical R&D business partners to ensure compliance with purchasing controls requirements, including risk classification, group categorization, and audits. Support development and finalization of supplier quality agreements as the needed.
• Attend and support Quality System, Preclinical and Clinical R&D management, and any relevant program/ study-level compliance reviews in support of CSS Business.

Compliance Assessments / Audits

• As needed, may conduct Preclinical and/ or Clinical audits of sponsor oversight, biocompatibility/ toxicology, clinical investigator sites, Preclinical & Clinical vendors, or Preclinical & Clinical processes.
• Consult with business partners and RDQ peers to provide guidance on Quality Issues, nonconformances (NC) and Corrective and Preventative Action Plans (CAPA). Develop NCs and/or CAPAs, as required. Ensure adequacy of failure investigation plans and track action plans / CAPAs to closure.

Inspections

• Partner with Regulatory Compliance to develop and align to inspection strategies, including preparation, execution, and resolution activities for Health Authority Inspections.
• Prepares the team and hosts regulatory inspections with clinical and / or preclinical scope. Acts as SME to support internal audits and inspections where clinical and / or preclinical support is needed (JJRC, ERC, etc.). Provide inspection readiness training to internal teams and clinical investigator site personnel as needed.

Team Leadership, Cross-Functional Collaborations & Execution

• Collaborate with the Quality Head, Quality Assurance, and other quality functions to develop and implement an effective GLP / GCP quality program.
• Lead and/or participate in cross-functional, cross-segment and/or cross-business working groups to deliver key initiatives.

Qualifications

Education:

• University/Bachelors degree or equivalent in Scientific field is required.
• Advanced degree in Science or Business is preferred.

Experience and Skills

Required:

• Six to eight (6-8) years of related experience.
• Experience in a medium- to large-scale, life sciences organization.
• Medical device/MedTech industry or equivalent healthcare industry experience.
• Strong working knowledge of 21 CFR Part 58, ISO14155:2020, ICH-GCP, 21 CFR Part 11, 21 CFR 812 and other relevant standards and regulations for preclinical and clinical research.
• Health authority inspection experience is desirable.
• Demonstrated experience engaging and establishing partner relationships.
• Innovative approach to build and maintain a competitive advantage.
• Ability to motivate colleagues and partners at all levels of the organization.
• Conflict resolution, management, and negotiation skills.
• Ability to articulate complex concepts or issues to non-expert business partners or Leadership Teams.
• Exceptional written and verbal communication skills in English.
• Strong project management and execution skills.
• Ability to interpret data to develop action plans as part of risk mitigation and / or continuous improvements as part of risk mitigation and / or continuous improvements.
• Ability to prioritize tasks, lead several projects simultaneously, and operate effectively in a multi-disciplinary environment.
• Demonstrate leadership skills and experience leading a cross-functional team to deliver results.
• Significant work experience with a track record of working independently across functions and business units in a manner that is aligned with J&J Credo.

Preferred:

• Licensing, mergers/acquisitions and consulting experience.
• Experience in a customer/external facing role.

Other:

About Laminar

• Laminar is a clinical stage medical device company advancing transseptal left atrial appendage (LAA) closure. The LAA is a small pouch in the left atrium of the heart that is a major contributor to thromboembolic stroke in patients with atrial fibrillation. It has developmental, ultra-structural, and physiological characteristics distinct from the left atrium proper. Growing incidence of atrial fibrillation and medical device developments have rapidly expanded the market.
• Ability to travel domestic, up to 25%, is required.
• The anticipated base pay range for this position is $99,000 to $170,200.
• The anticipated base pay range for this position is, in the Bay Area, is $113,000 to $195,730.

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 June 7, 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.