Commercial Operations Lead

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Act as the main quality representative for the Field Sales Network.

• Ensure adherence to internal quality standards, SOPs, work instructions, and regulatory requirements.

• Oversee quality metrics, observations, CAPAs, effectiveness monitoring activities, and audit action plans.

• Lead preparations for audits and coordinate internal audits, ERC audits, JJIA audits, FDA inspections, and other compliance evaluations.

• Create audit preparation strategies, opening presentations, readiness documentation, and supporting materials for sites.

• Provide coaching to site leaders and FSN management on inspection preparedness and audit best practices.

• Assist with audit response activities and the implementation of corrective actions.

• Drive the investigation, remediation, and resolution of quality observations.

• Collaborate with cross-functional teams to develop sustainable corrective and preventive actions.

• Track aging metrics and effectiveness monitoring activities.

• Author, review, revise, and approve SOPs, work instructions, training materials, and operational procedures.

• Standardize practices across FSN sites through Operations Excellence.

• Coordinate field actions, including recalls, quarantines, and stop shipment initiatives.

• Evaluate inventory impacts while maintaining governance and reporting for stop shipment activities.

• Monitor compliance with quality training and deliver training on quality procedures and operational standards.

• Advocate for quality, inspection preparedness, and continuous improvement.

• Collaborate with FSN leadership, Site Leads, Commercial Quality, Facilities, Supply Chain, Systems, and Franchise Quality teams.

• Provide consultation on operational changes, risk assessments, and quality implications.

• Influence stakeholders to develop compliant and practical business solutions.

⛳️ Requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, Supply Chain, Business, or a related field.

• Over 5 years of experience in Quality, Operations, Regulatory, Compliance, Supply Chain, or Medical Device sectors.

• Proven experience managing CAPAs, audits, investigations, observations, or quality systems.

• Strong skills in project management and stakeholder management.

• Excellent communication and presentation skills.

• Willingness to travel approximately 25-40% of the time.

• Preferred experience in the medical device, pharmaceutical, healthcare, or regulated industry.

• Prior experience supporting audits and regulatory inspections is preferred.

• Familiarity with Good Documentation Practices (GDP), CAPA, complaint handling, change control, and risk management is preferred.

• Experience with EtQ, Windchill, SAP, Move Medical, Power BI, or similar platforms is preferred.

• ASQ certification, Lean/Six Sigma certification, or equivalent quality credentials are preferred.

🏝️ Benefits

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year 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 rolling 52-week period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• Inclusive interview process and accommodations for disabilities.

• Commitment to equal opportunity employment.