4 дня назад
Director, Technical Quality & Compliance (MedTech)
150 000 - 258 750$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Technical Quality & Compliance (MedTech): Leading medical device regulatory quality activities and computerized systems validation across the product lifecycle with an accent on GxP compliance, data integrity, SDLC governance, and regulatory readiness. Focus on building quality controls into applications and cloud infrastructure, guiding global teams, and driving quality system transformation.
Location: Hybrid role based in West Chester or Raritan, New Jersey; Palm Beach Gardens, Florida; or Raynham, Massachusetts, United States. Moderate international travel is required.
Salary: $150,000–$258,750 base pay per year.
Company
Johnson & Johnson MedTech develops healthcare and medical device solutions, with the Orthopedics business planned to operate as the standalone DePuy Synthes company.
What you will do
- Provide strategic leadership for medical device regulatory activities and technical quality and compliance.
- Ensure compliance with J&J quality standards and global regulatory requirements.
- Embed quality, controls, and automation into system design and development activities.
- Lead computerized systems and technology quality programs across applications and cloud infrastructure.
- Guide project teams on validation, quality approaches, end-to-end support models, and delivery accountability.
- Partner with regional leads and lead global, cross-functional teams in a matrixed environment.
Requirements
- 10–12 years of experience leading GxP computerized systems validation in pharmaceutical, medical device, biotech, or another regulated industry.
- Deep knowledge of GxP regulations, data integrity, SDLC governance, validation lifecycle management, electronic records and signatures, audit trails, and inspection readiness.
- Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field.
- English is required.
- Strong analytical, communication, change-management, collaboration, and technical leadership skills.
- Ability to work from one of the listed United States locations and undertake moderate international travel.
Nice to have
- Experience in medical devices, healthcare, or other highly regulated industries.
- Experience in global, matrixed organizations.
- Experience with electronic quality management and training systems.
- Quality system transformation or harmonization experience.
- Quality or regulatory certifications such as ASQ, RAC, CSQE, SQE, SQA, or PMP; additional European languages.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and equal opportunity.
- Eligibility for pension and 401(k) savings plans.
- Participation in the long-term incentive program.
- Paid vacation, sick time, holidays, personal and family time, parental, bereavement, caregiver, volunteer, and military spouse leave.
- Hybrid work arrangement with international collaboration.
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