Senior Quality & Compliance Specialist

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $94k - $151.8k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• Develop, execute, and oversee Quality and Compliance programs for the orthopedic last-mile operations network in the United States • Support internal and external orthopedic last-mile Field Inventory operations, Loaner Sites, and Distribution Centers • Collaborate with Quality, Supply Chain, Delivery, Sales, and Commercial partners on distribution and commercial quality matters • Drive timely resolution of quality-related issues and support implementation of improvement opportunities • Define, implement, and validate quality requirements and systems • Serve as the single point of contact for assigned operations • Host and lead audits, inspections, investigations, and remediation activities • Ensure the Quality program maintains regulatory compliance • Provide quality support for existing and new distribution processes and go-to-market models • Develop, implement, and review standard operating procedures • Maintain relationships with orthopedic last-mile operations and Franchise customers • Execute and improve inspection readiness, process changes, validation, calibration, preventive maintenance, and delivery service issue processes • Investigate nonconformances and develop, implement, and monitor corrective action plans for effectiveness • Coach and mentor functional areas on ISO and cGMP requirements

🎯 Requirements

• A minimum of a Bachelor's or equivalent University degree is required • 6–7 years of relevant work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment • Working knowledge of FDA regulations CFR 820, ISO 13485, ISO 9001, and quality system requirements relevant to medical devices, commercial distribution, and field inventory environments • Experience supporting quality systems, document control, training compliance, quality metrics, audits, nonconformance management, corrective action processes, or related compliance activities • Experience using quality system IT platforms such as Windchill, ETQ, DMS, LMS, QEM, Summit, change control systems, ERP systems, warehouse management systems, or related tools preferred • Ability to communicate and collaborate effectively with cross-functional partners • Ability to follow established procedures, complete assigned work accurately and on time, maintain organized records, and escalate issues when needed • Critical thinking, problem-solving, and root cause analysis skills • Working knowledge of standard quality system requirements, good documentation practices, technical writing, nonconformance, and CAPA • Proficiency with Microsoft Office, data analysis, and quality system applications • Preferred experience with Windchill, ETQ, Summit, ERP, or warehouse management systems • Preferred experience with audit preparation, inspection readiness, regulatory responses, or health authority interactions • Preferred certifications or training in Lean, Six Sigma, 5S, ASQ, ISO 13485, Good Distribution Practices, supplier quality, or other quality improvement methods • May require up to 25% domestic and international travel

🏖️ Benefits

• Retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington • Holiday pay, including Floating Holidays – 13 days per calendar year • Work, Personal and Family Time – up to 40 hours per calendar year • Parental Leave – 480 hours within one year of birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year • Employee benefits described at https://www.careers.jnj.com/employee-benefits