Senior Director, Quality Compliance

Company: Sequel Med Tech
Location: Manchester
Posted on: April 23, 2025

Job Description:

About SequelSequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.Job OverviewReporting to the Vice President of Quality, the Senior Director of Quality Compliance is responsible for leading quality/compliance functions in accordance with the United States and any other applicable regulatory requirements. The scope of the role is expected to grow as Sequel's scope of activities might further evolve. This leader, reporting to the VP of Quality, will ensure that Sequel's quality management processes meet regulatory standards and support the company's mission.As the primary Sequel Med Tech employee overseeing this critical area, the Senior Director's initial focus will be leading the company's transition from Quality System Regulation (QSR) to a harmonized Quality Management System Regulation (QMSR) by 2026. This transition will involve developing a comprehensive quality transition plan and guiding the company's change management processes. In this role, the Senior Director will meticulously document each transition step and communicate updates across departments to ensure alignment and regulatory adherence.This position offers an exciting opportunity for a regulatory and quality systems expert to lead a pivotal transformation within a growing medical device company.Job Responsibilities and Essential Duties

• Lead QMS Transition to QMSR: Oversee and actively manage Sequel's transition from Quality System Regulation (QSR) to the FDA's Quality Management System Regulation (QMSR) standards, ensuring full alignment with 2026 compliance requirements. Develop and execute the transition plan, implement necessary process adjustments, and coordinate organization-wide adherence to meet the deadline.
• Interpret and implement GMP requirements: Provide expert guidance in interpreting FDA and other relevant government regulations. Develop and enforce internal policies and procedures to ensure regulatory compliance within Sequel's quality systems, aligning all processes with the latest regulatory standards.
• Direct Quality Teams: Lead quality teams, including both senior leaders and individual contributors, to meet organizational goals and compliance objectives. Ensure these teams execute on regulatory mandates effectively, fostering a high-performance culture.
• Enhance Quality Ownership Across Functions: Drive quality-focused projects that instill accountability for accuracy, consistency, and completeness across all Sequel departments, ensuring operational alignment with regulatory expectations.
• Lead the Promotional Material Review process for Sequel: Manage the regulatory review process for promotional materials, ensuring they meet FDA requirements and accurately reflect approved product claims and messaging.
• Obtain and Maintain U.S. State Licenses: Lead efforts to secure and maintain distribution rights across U.S. states, focusing on state-specific licensing requirements for Sequel's products.
• Support Compliance Tool Implementation: Collaborate with cross-functional teams to implement tools and systems necessary for regulatory compliance, helping Sequel meet both quality and business objectives.
• Collaborate with Legal on Compliance: Partner closely with Sequel's Legal Compliance team to ensure all regulatory standards are met across the organization, maintaining Sequel's standing with regulatory agencies.
• Provide FDA Regulatory/GMP Training: Regularly train and educate cross-functional teams on applicable FDA and regulatory standards to build an organization-wide understanding of the regulatory environment and requirements.
• Ensure Audit Readiness: Oversee audit preparation for all quality-related activities, ensuring Sequel is always prepared for both scheduled and unscheduled regulatory audits.
• Represent Quality in External Audits: Serve as the primary Quality representative during external audits, communicating Sequel's compliance and regulatory strategies to auditors.
• Ensure Partner and Supplier Compliance: Work closely with Sequel's partners and suppliers to enforce compliance with U.S. regulatory requirements, ensuring all outsourced processes align with Sequel's quality standards.
• Monitor and Report Regulatory Intelligence: Oversee regulatory intelligence for the U.S. market, regularly updating cross-functional teams on regulatory changes and guiding timely implementation of necessary adjustments.Minimum Requirements
  • Bachelor's degree in life sciences preferred. Advanced degree with a focus on business or regulatory affairs strongly preferred.
  • 10+ years of progressive experience in quality and regulatory affairs, with a primary focus in medical device regulatory affairs.Required Knowledge, Skills and Abilities
    • Comprehensive knowledge of and experience with U.S. medical device regulations, Quality Management System Regulation, and Medical Device Software. Experience with electromechanical medical devices preferred.
    • Demonstrated experience successfully meeting and negotiating with the FDA.
    • Demonstrated experience preparing major regulatory submissions and supportive amendments or supplements.
    • Experience in the field of convenience kits is a plus.
    • Demonstrated ability to build strong cross-functional relationships to drive business needs.
    • Demonstrated negotiation and communication skills.Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.At Sequel, we believe that when you thrive, we thrive. That's why we've designed a benefits package that's as thoughtful as it is generous. From day one, you're automatically enrolled in our 401k plan-no waiting, no worries-with a 6% company match and 100% immediate vesting. We prioritize your well-being, especially for our employees and their families living with diabetes, with capped out-of-pocket insulin costs and GLP-1 coverage across all plans. With multiple medical plans through Aetna, including a 100% company-paid high deductible plan paired with employer HSA contributions, you can select what suits your needs. Additional benefits include vision and dental plans, employer-paid short-term disability, and voluntary options like accident and pet insurance.Need time to relax and recharge? You'll enjoy flexible PTO and generous paid holidays, all while being part of a culture that values hard work, fun, and support. We don't just offer jobs-we offer careers that build futures. Join us, and let's grow together!Environmental/Safety/Physical Work Conditions
      • Ensures environmental consciousness and safe practices are exhibited in decisions
      • Use of computer and telephone equipment and other related office accessories/devices to complete assignments
      • May work extended hours during peak business cycles
      • Physical requirements such as lifting specific weights
      • Some travelling is expected
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Keywords: Sequel Med Tech, Arlington , Senior Director, Quality Compliance, Executive , Manchester, Massachusetts