Director of Quality Assurance

Planet Pharma; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Planet Pharma is seeking a Director of Quality Assurance to provide strategic and operational leadership for QA and GXP activities across development and commercial stages. You will manage the Quality Management System, lead QA personnel, and ensure compliance with US FDA regulations and ISO standards, while guiding continuous improvement and facilitating regulatory filings.

The role requires extensive experience in medical devices or device-combination products, strong vendor management, and

Qualifications

• Bachelor degree in a scientific discipline; advanced degree preferred.
• Minimum 10 years in Quality Assurance with at least 5 years in management.
• Experience with medical devices in development and commercial stages.
• Experience managing quality systems for virtual organizations.
• Expert knowledge of US FDA regulatory requirements and ISO standards.
• Experience with risk management and vendor/CMO management.
• Willingness to be a Designated Representative for CA Board of Pharmacy.
• Domestic and international travel as needed.

Responsibilities

• Lead and maintain the Quality Management System across QA activities.
• Develop and review GXP policies, SOPs, and related documents.
• Oversee QMS programs: change control, deviations, investigations, CAPAs, metrics.
• Manage internal and external audits and regulatory inspections.
• Lead QA training programs and supplier qualification activities.
• Provide QA guidance for clinical studies, CMC, and product development.
• Oversee post-marketing surveillance and product release activities.
• Coordinate with Regulatory to support submissions and information requests.
• Mentor QA staff and drive department growth.

Skills

QA leadership

Regulatory compliance

GXP expertise

Vendor management

Cross-functional leadership

Veeva QMS

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Tools

Veeva QMS

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