Supervisor Quality Compliance

Accountabilities:

• • Lead and oversee the Quality Compliance team, managing daily activities, priorities, performance, development, and accountability.
  • Build and maintain a strong culture of quality, compliance, candid communication, continuous improvement, and inspection readiness.
  • Manage regulatory, internal, third-party, and customer audits and inspections, including preparation, execution, observations, responses, and follow-up activities.
  • Own and maintain the inspection readiness program, including training, readiness assessments, facility walkthroughs, steering committee activities, budgets, and audit management systems.
  • Serve as a key representative during regulatory inspections, including front-room and back-room coordination, document production, and communication with inspectors and authorities.
  • Lead internal audit planning and execution using risk- and budget-based approaches, ensuring findings are appropriately documented and addressed.
  • Oversee CAPA activities, root-cause investigations, risk assessments, audit responses, and remediation strategies to prevent recurrence of compliance issues.
  • Manage Quality Management Review and Quality Review Board programs, ensuring governance processes, meeting requirements, metrics, and documentation remain compliant and effective.
  • Oversee Field Alert and regulatory notification processes, ensuring submissions are accurate and completed within required timelines.
  • Manage the product recall system, including mock recalls and coordination with internal stakeholders, affiliates, distributors, and regulatory agencies.
  • Lead the Annual Product Quality Review process from scheduling through completion, reviewing product quality metrics, identifying trends, and ensuring appropriate corrective actions.
  • Develop and maintain quality KPIs, analyze trends, and prepare management reporting and presentations for senior leadership.
  • Develop, implement, review, and approve Quality Compliance policies, procedures, SOPs, and related documentation.
  • Provide regulatory interpretation and guidance regarding changing FDA, international, GMP, GDP, GLP, ISO, and industry requirements.
  • Collaborate with local, global, and cross-functional teams to standardize processes and implement quality improvements.
  • Coach, mentor, train, and develop Quality Compliance employees, including participation in hiring, onboarding, performance evaluations, and professional development.
  • Support GMP, GDP, and quality systems training and contribute to cross-functional initiatives as a Quality Compliance subject matter expert.

  Requirements:

  • Bachelor’s degree in a scientific, engineering, or technical discipline.
  • At least 8 years of experience in Quality and/or Compliance within the pharmaceutical industry.
  • At least 5 years of experience managing inspections and audits, including regulatory and/or internal audits; relevant certifications may be considered in lieu of some experience.
  • At least 3 years of experience leading or managing quality system elements, such as deviations/nonconformances, internal audits, training, and Annual Product Quality Reviews.
  • Strong knowledge of FDA and international regulatory requirements applicable to pharmaceutical and/or medical device environments.
  • Working knowledge of drug or device cGMP requirements and ISO 13485, along with familiarity with GMP, GDP, and GLP principles.
  • Strong understanding of Quality Management Systems, Quality Assurance principles, risk management, risk assessments, and data integrity.
  • Demonstrated experience conducting and managing internal and external audits and regulatory inspections.
  • Strong analytical and problem-solving abilities, including the ability to interpret quality data, identify trends, assess risks, and determine appropriate corrective actions.
  • Exceptional attention to detail and accuracy when reviewing quality records, reports, procedures, and regulatory documentation.
  • Excellent written and verbal communication skills, with the ability to prepare executive-level reports, deliver training, and communicate effectively with regulatory authorities.
  • Strong leadership, coaching, mentoring, and interpersonal skills, with the ability to manage direct reports and collaborate across departments.
  • Experience working with electronic Quality Management Systems (EQMS), Electronic Document Management Systems (EDMS), and related systems; ability to create queries and reports is valuable.
  • High ethical standards, professional integrity, sound judgment, and a strong commitment to compliance.
  • Ability to work proactively and adapt effectively in a changing, highly regulated environment.
  • Preferred certifications include Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), ASQ Certified Supplier Quality Professional (CSQP), Six Sigma, or other relevant quality credentials.
  • Willingness to work on-site for regulatory inspections and marketing partner audits and undertake occasional domestic or international travel.

  Benefits:

  • Annual salary range of $100,000–$115,000, depending on experience and qualifications.
  • Eligibility for a performance-based bonus.
  • Comprehensive employee benefits package.
  • Market-based compensation and commitment to equitable and fair pay practices.
  • Primarily on-site work environment in Fort Collins, Colorado.
  • Opportunities to lead a high-impact Quality Compliance function within a highly regulated pharmaceutical setting.
  • Professional development and opportunities to strengthen regulatory, quality, leadership, and compliance expertise.
  • Collaborative, cross-functional environment with exposure to senior leadership and regulatory stakeholders.
  • Equal employment opportunity and commitment to an inclusive workplace.