Director of Quality Assurance

Job description

Position Title: Director of Quality Assurance

POSITION SUMMARY

The Director of Quality Assurance provides strategic and operational leadership for the Quality and GXP activities. We area commercial and development stage company with an approved complex drug-device combination product and a development pipeline of device products. The Director of Quality Assurance manages theQuality Management System, QA personnel, and Quality initiatives, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. S/he translates the company’s quality strategy into tactical and pragmatic policies, processes, and procedures to effectively meet global standards and ensure the overall quality ofproducts. S/he will collaborate closely with the Head of Quality and Regulatory Affairs, internal functional areas, external partners, contract facilities, and suppliers to drive continuous improvement in quality and support regulatory compliance and product safety from early product development through the post-marketing stage of product lifecycles.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Manages and maintains an effective Quality Management System, ensuring compliance with US FDA regulations, ISO 13485, and global regulatory requirements. Create, maintain, review, and approve GXP-related Policies, SOPs (Standard Operating Procedures), and supporting GXP documents.

Leads the programs and processes within the QMS, including change control, deviations and investigations, complaints, CAPAs, metrics and reporting.

Develops and manages GXP training programs for personnel in collaboration with the other functional heads.

Maintain and implement the supplier qualification program, including conducting supplier audits, developing quality agreements, and monitoring supplier performance.

Implements the internal audit program.

Serves as the primary back-up system administrator for the Veeva EDMS.

Ensures inspection readiness and, in coordination with the Head of Quality and Regulatory Affairs, manages regulatory inspections and audits.

Develops and implements strategies for continuous quality improvement to support evolving regulations, product innovation, and a strong Quality culture across the organization.

Provides Quality and CMC guidance and oversight during new product due diligence, product development, and commercialization.

Provides Quality guidance for clinical studies to ensure GCP compliance, qualification of suppliers, and execution ofSOPs

Performs product release for investigational and commercial distribution.

Oversees product complaints and reviews post-marketing surveillance reports.

Works closely with the Regulatory function to develop Quality and CMC content for submissions, manage DHFs, address Quality and CMC information in information requests, and represent the Quality function in regulatory interactions.

Participate in supply chain planning and commercial distribution activities.

Monitors and assesses the impact of new regulatory requirements on the company, QA function, and product pipeline.

Establishes and maintains the internal library of standards and technical publications

Manages relationships with external quality partners, including vendors and consultants

Oversees the effective administration of the internal EDMS for the company.

Manages and mentors QA personnel for career development and advancement.

ESSENTIAL SKILLS & QUALIFICATIONS

Bachelor level degree in a relevant scientific discipline; advanced degree is preferred

Minimum of 10 years of Quality Assurance experience, with at least 5 years in a management role

Experience developing, managing, and maintaining Quality systems for medical devices in development and commercial stages is required; experience with combination products is desired

Experience implementing Quality systems at virtual organizations (e.g., specification developer)

Expert knowledge of US FDA Regulatory requirements (cGMP / GLP / GCP / GVP / QMSR / ISO) and other applicable (e.g., international) standards of compliance

Experience applying risk management principles to decision making

Experience engaging vendors and CMOs, including relationship management and performance monitoring

Ability and willingness to be certified as a Designated Representative for a Wholesaler through the CA State Board of Pharmacy

Availability for travel, both domestic and international

Requires strong organizational and technical skills (e.g., word processing, spreadsheets, databases, online research)

Experience with Veeva QMS is preferred

Requires excellent verbal, written, and communication skills

Ability to prioritize multiple assignments in a fast-pace office environment and communicate those priorities within the department, to leadership, and across cross-functional teams

Ability to effectively communicate with and manage multiple external partners and teams, locally and globally, including availability for collaboration across multiple time zones

Ability to work independently and as a team player cross-functionally

Ability to effectively manage and lead the department and, when needed, cross-functional teams

Ability to effectively develop a department and its personnel, including coaching and mentoring

IN OFFICE PRESENCE

Tuesday, Wednesday & Thursday in San Francisco

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Worksite address

san francisco, CA, 94199, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.