[Hiring] Commercial Operations Quality Lead @Johnson & Johnson Innovative Medicine

Role Description

Commercial Operations Quality Lead serves as the primary quality partner for the Field Sales Network (FSN), ensuring compliance with Johnson & Johnson quality systems, regulatory requirements, and internal standards across a national network of field inventory locations.

• Partner closely with FSN leadership, site leads, Commercial Quality, Operations Excellence, Facilities, and business process teams.
• Drive audit readiness, quality system compliance, process standardization, corrective and preventive actions (CAPAs), inspection management, field actions, stop shipments, training compliance, and continuous improvement initiatives.
• Combine strong quality and compliance expertise with operational leadership and influencing skills.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Supply Chain, Business, or related field.
• 5+ years of experience in Quality, Operations, Regulatory, Compliance, Supply Chain, or Medical Device environments.
• Experience managing CAPAs, audits, investigations, observations, or quality systems.
• Strong project management and stakeholder management skills.
• Excellent communication and presentation abilities.
• Ability to travel approximately 25-40%.

Requirements

• Medical device, pharmaceutical, healthcare, or regulated industry experience (preferred).
• Experience supporting audits and regulatory inspections (preferred).
• Knowledge of Good Documentation Practices (GDP), CAPA, complaint handling, change control, and risk management (preferred).
• Experience with quality systems such as EtQ, Windchill, SAP, Move Medical, Power BI, or similar platforms (preferred).
• ASQ certification, Lean/Six Sigma certification, or equivalent quality credentials (preferred).

Benefits

• Vacation – 120 hours per calendar year.
• Sick time - 40 hours per calendar year; 48 hours for employees in Colorado; 56 hours for employees 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 the 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.