Director, Quality Microbiology

Integra LifeSciences Corporation; Irvine (CA); Sur place; USD 167 000 - 229 000; Plein temps

Résumé du poste

Integra LifeSciences Corporation is seeking a Director of Quality Microbiology to lead microbiology teams across Tissue Technologies and Codman Surgical Specialties. You will drive strategy, mentoring, and collaboration with quality, operations, R&D, and global supply to ensure manufacturing compliance and patient safety.

The role reports to Corporate Quality Sterility Assurance and is based in Princeton with travel flexibility as needed.

Qualifications

• Minimum 12 years of experience in medical devices or regulated industry.
• 5 years of leadership experience in microbiology.
• Experience with FDA inspections and regulatory audits.

Responsabilités

• Provide training, mentoring, and development support for microbiology personnel.
• Collaborate across quality, operations, R&D, Global Supply, Finance, Sales, and Marketing to meet company goals.
• Act as global process owner for microbiology and document implementation of Global procedures.
• Lead and sustain strategies for the Quality Microbiology team and report KPIs.
• Oversee microbiology programs and ensure compliance across manufacturing sites.

Connaissances

Team leadership

Microbiology

Quality systems

Regulatory inspections

Cross-functional collaboration

Formation

Master of Science in Microbiology

Bachelor’s degree in Microbiology

Description du poste

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Full time

JR-6219

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Director, Quality Microbiology, is responsible for leading Integra LifeSciences operational microbiology teams across the Tissue Technologies and Codman Surgical Specialties businesses. Qualified candidates must possess relevant experience with Subject Matter Expertise in the following areas:

• Controlled environment qualification and monitoring
• Water system qualification monitoring
• Bacterial endotoxin test method validation and monitoring
• Bioburden test method validation and monitoring
• Contamination control systems (monitoring, gowning, aseptic techniques, cleaning, etc.)

The candidate must be an experienced team leader who leverages the talent of their team to increase performance, generate results, and maintain robust quality of manufacturing site microbiology programs. This position reports to Corporate Quality Sterility Assurance and will be located in Princeton or another Integra facility with flexibility for travel as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Provide technical talent training, mentoring, and development support for microbiology personnel and cross-functional teams
• Serve as a representative for microbiology globally and collaborate across functions such as quality, operations, R&D, Global Supply, Finance, Sales, and Marketing to ensure company goals are met
• Act as a global process owner for microbiology and oversee the implementation of Global procedures to support compliance of Integra LifeSciences manufacturing site Microbiology Quality programs
• Create and sustain long-term strategies and advise a team of managers and scientists across the Quality Microbiology team
• Provide leadership and direction to the Quality Microbiology team to ensure business, quality, and compliance objectives are met
• Report results of site microbiology programs to leadership for projects and key performance indicators
• Resource business projects such as manufacturing transfer, acquisitions, new product development, etc. with microbiology personnel
• Participate as a microbiology SME in internal audits, and external audits such as FDA inspections, ISO certifications, surveillance audits and customer audits.
• Maintain a strong working knowledge of standards and regulations including FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.

DESIRED MINIMUM QUALIFICATIONS

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

REQUIRED EXPERIENCE

• Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.
• Minimum 12 years’ experience in medical device or regulated industry with 5 years of leadership experience, with experience in microbiology.

PREFERRED EXPERIENCE

• Experience working with the manufacturing of tissue-based products and surgical tools as a microbiologist or similar scientific discipline in the medical device industry
• Experience leading teams in the development and implementation procedures used in operations across multiple businesses/manufacturing sites.
• Advanced communication skills (written and verbal) with the ability to curate information to a diverse audience of stakeholders
• Robust cross-functional collaboration skillset with the capability of driving quality and operational excellence
• Advanced team leadership experience including mentoring, meeting facilitation, coaching, influencing, and negotiation
• Capable of working autonomously and with independence when needed while maintaining strong performance
• Demonstrated capability to develop strategic direction, goals, and guiding execution in a team-based working environment
• Advanced experience working within Quality Systems including, but not limited to, change control, CAPAs, deviations, nonconformances, risk assessments
• Direct experience representing a department in regulatory inspections and communications
• Advanced technical writing skillset with the capability to interpret and author complex documentation
• Working knowledge of applicable microbiology standards including, but not limited to, FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.
• Ability to travel up to 25%.

Salary Pay Range:

$166,750.00 - $228,850.00 USD Salary

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 (https://www.integralife.com/careers/total-rewards)

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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Whatever your specialty, you’ll find an ideal setting for building a rewarding career.

Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.