Senior Director, Quality Assurance

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

📋 Description

• Lead the quality strategy and manage quality systems throughout the launch and early commercialization phases in the US.

• Supervise GxP quality activities encompassing manufacturing, supply chain, distribution, quality systems, and vendor management.

• Ensure preparedness for inspections and maintain ongoing compliance.

• Offer quality leadership to guarantee readiness for commercial launches.

• Manage batch disposition, product release protocols, complaint resolution, deviations, CAPAs, change control, and product quality evaluations.

• Develop and sustain a scalable quality management system that transitions from clinical-stage to commercial readiness.

• Ensure adherence to FDA, ICH, and global GxP standards.

• Establish and supervise commercial quality processes, including final product release/disposition, supply chain security, and distribution quality measures.

• Provide quality oversight for GLP, GCP, and GMP vendors.

• Lead vendor qualifications, conduct audits, and manage quality agreements with contract manufacturing and research organizations.

• Manage deviations, CAPAs, change controls, and quality investigations.

• Identify compliance risks and provide guidance to executive management on regulatory changes.

• Influence executive decision-making regarding quality and regulatory strategies through data-driven communication.

• Develop, implement, and maintain GxP SOPs, policies, and controlled documents.

• Establish and manage a company-wide GxP training program.

• Oversee product complaint management, coordination of adverse event reporting, and annual product quality reviews (APQR).

• Collaborate with executive leadership to implement company-wide quality policies and practices.

• Lead and nurture the quality organization through subordinate managers and team members.

• Execute additional responsibilities, initiatives, and special projects as business needs evolve.

⛳️ Requirements

• A Bachelor of Science degree in a life science discipline (biology, chemistry, etc.) is required; an advanced degree is preferred.

• Over 10 years of industry experience in Quality Assurance within the pharmaceutical or biotech fields.

• A minimum of 8 years in a leadership capacity.

• Proven ability to develop and articulate a company-wide quality strategy, vision, and direction.

• Demonstrated success in leading a quality function through a US commercial product launch and transitioning from clinical to commercial GxP requirements.

• Expert-level knowledge of US FDA GxP and ICH requirements.

• Experience with European (EMA) or APAC regulations is highly desirable.

• Proven track record in developing and implementing company-wide QMS platforms and managing complex quality investigations.

• Strong interpersonal and communication skills with a collaborative approach to working with cross-functional project teams and external partners.

• Willingness to travel up to 30% (domestic and international) for vendor audits and site visits as necessary.

• Proven experience in negotiation and influence at the executive level.

• Ability to align quality strategy with organizational objectives.

🏝️ Benefits

• Health Insurance

• Dental & Vision Insurance

• Healthcare & Dependent Care FSA

• Employee Assistance Program (EAP)

• 401(k) Savings Plan

• Long-term Incentive Plan

• Life Insurance

• Accident & Disability Insurance

• Telemedicine

• Generous Paid Time Off

• Company Holidays