Director, Quality Assurance

Location
Working from home
Posted
Sep 17, 2020
Ref
572495236
Required Education
Bachelors Degree
Position Type
Full time
Who You Are

Reporting to the Vice President, Quality Assurance, the Director of Quality Assurance is responsible for the development, maintenance, and oversight of GXP activities related to overall drug development. Responsibilities will be to ensure quality and compliance of GXP drug development activities with respect to company policies and procedures, applicable regulatory requirements (US FDA, ICH, and country-specific), along with current industry standards and practices. The position will work closely with Clinical and CMC teams to manage and support a culture of quality, regulatory compliance, and continuous GXP inspection readiness. The Director of QA will assist in the creation, management, and continuous improvement of Origin's quality management system (QMS) by collaborating and developing strong relationships internally and partnerships externally to ensure appropriate processes, systems, and activities are in place to protect the rights, safety, and welfare of study subjects.

Responsibilities
  • Implement a comprehensive quality management system (QMS) that will ensure QA oversight of internal and external activities including current good manufacturing, clinical, laboratory, and distribution practices (i.e. GXP)
  • Ensure compliance with domestic and international current quality guidelines and GXP regulations
  • Ensure clinical and commercial drug products are manufactured, tested, released, and distributed in accordance with Origin's established specifications, procedures, clinical requirements, and appropriate GXP standards
  • Implement a GXP vendor quality management program, including vendor audits and quality agreements
  • Develop and implement processes to prepare for and manage regulatory agency inspections
  • Attend cross-functional team meetings and provide GCP guidance to clinical study teams based on interpretation of current regulations to ensure best practices including risk-based management
  • Batch record review, exception management (deviation and investigation controls, material review board, product complaints, and corrective and preventative actions)
  • Lot disposition activities for both clinical and commercial drug substance, drug product batches, and clinical trial packs
  • Quality oversight of stability transfer and stability program
  • Oversee GMP activities associated with the commercial launch
  • Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation
  • Other duties as assigned or required

Education, Experience & Skills Requirements
  • Bachelor's degree in a scientific discipline is required. An advanced degree in a scientific discipline is preferred
  • Minimum of 7+ years of progressive responsibility in pharmaceutical/biotech GXP-related Quality environments
  • In-depth working knowledge o fGXPs
  • Leads by example and highly collaborative with the proven ability to work in a cross-functional internal and external teams
  • Communication skills: must be able to lead, manage, and complete GXP quality projects in a fast-paced, growing environment
  • Must be able to prioritize work effectively to ensure the progression of multiple departments and corporate timelines
  • Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct, and track deliverables.Ability to travel at least 25% to various meetings including overnight trips. Some international travel may be required
  • Pro-active in identifying opportunities along with strong problem solving and negotiation skills

What We Offer
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so