Japanese Project Manager Jobs in Massachusetts (NOW HIRING)

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SUMMARY

The VP, Corporate Quality Systems is a key member of the Quality Leadership Team (QLT) with responsibility to design, implement and oversee the Integra Global quality system, including identifying compliance improvement and remediation strategies across Integra LifeSciences. This role will work cross-functionally across all Integra facilities to build an integrated Quality system infrastructure that supports continued compliance across Integra sites. This role is crucial for ensuring the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies.

SUPERVISION RECEIVED

Reports to the Chief Quality Officer.

SUPERVISION EXCERCISED

Directly manages a Quality system corporate team (CAPA, NCE, Doc Control, Management Controls, Training/L&D, Audit/Compliance, Corporate Headquarters Site Quality, and Post Market Surveillance).

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as follows:

• Build a high-performance quality culture and team, empowering and holding direct reports and cross-functional teams accountable for successful quality and compliance transformation. Leads with authority and influences globally across manufacturing and distribution facilities and cross functional stakeholders including but not limited to quality, product development, process technology, operations, supply chain, procurement, regulatory affairs, finance, and human resources.

• Develop organizational design and governance to achieve success. Provide strategic direction and communication of the quality transformation goals, creating a clear vision and integration with overall business objectives. Develop and monitor key performance indicators (KPIs) to assess the effectiveness of quality and compliance remediation. Highlighting trends, risks, and opportunities for improvement.

• Leads the design, execution and evolution of the Global Quality System for Integra in conjunction with the Compliance Master Plan (CMP) team, requiring cross-functional collaboration and understanding of various roles within the organization.

• Support interactions with regulatory bodies and ensure compliance with all applicable quality and safety standards. Responsible for leading the team with the review and finalizing any responses to regulatory authorities in collaboration with the Chief Quality Officer.

• Lead the identification, analysis, and resolution of quality issues and non-conformities across various departments in collaboration with the Quality Systems and CAPA teams. Ensure remediation efforts are managed through the QMS.

• Foster a culture of quality and continuous improvement within the organization. Promote the use of lean and Six Sigma methodologies to enhance quality and operational efficiency. Stay abreast of industry trends and advancements in quality management and remediation practices.

• Guide the activities required of the quality organization to ensure compliance with all appropriate regulations and standards, including FDA Part 820, ISO 13485, CMDR, MDR, MDSAP, and JPAL. Ensures compliance and readiness globally in collaboration with the QMS.

QUALIFICATIONS AND EXPERIENCE REQUIREMENTS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:

• Bachelor's degree is required, in engineering, science or closely related technical discipline is preferred. A master's degree preferred.

• 18+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience

• Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation experience

• Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.

• Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.

• Experience with direct contact with FDA and EU Notified Bodies.

• Knowledge of process design and implementation, change control, auditing, and document management systems required, general knowledge of statistical analysis preferred.

• Demonstrated organizational, management and communication skills. Proven track record of cross-functional collaboration across teams and change management skills. Strong ability to influence across all levels of the organization, including senior leadership. Experienced with interacting with Executive leadership to execute decisions and manage risk.

• Ability to travel up to 50% if needed based on site needs. Regular on-site presence in Massachusetts and New Jersey facilities.

PERSONAL COMPETENCIES

As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities.

• Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole.

• Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business. Works with a high level of strategic thinking.

• Drive Performance: Leaders with this capability drive performance and accountability through others and self.

• Enable Talent: Leaders with this capability strive toengage, support, and develop self and others, optimizing the success of individuals and teams and are experienced in dealing with change management.

Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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