GxP Compliance Director

Redwood City, CA Quality Assurance Full Time

The QA Director of GxP Compliance is responsible for leading corporate-wide GxP initiatives to ensure adherence to late-stage clinical and commercial multi-regional regulatory requirements, as well as corporate quality objectives. The candidate will have demonstrated successful development and implementation of robust quality processes supporting Clinical Development and Pharmaceutical Quality Systems.  

The individual must provide strategic leadership within the GxP compliance function. This includes the ability to work independently and also as an effective and engaged cross-functional leader and team member in a fast-paced environment. Strong initiative and independent follow-through are essential for this role. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. 

What you'll do:

  • Performs a wide variety of activities to lead GxP initiatives and to ensure compliance with quality objectives and regulatory requirements.
  • Stays abreast of evolving multi-regional regulatory requirements and develops strategies to assess and update internal quality processes accordingly.
  • Keeps current with Regulatory Intelligence and Global GxP requirements, and facilitates trainings/curricula to help others keep current.
  • Designs, develops and delivers high quality and high impact programs and services that provide functional, GxP and product knowledge for staff to achieve a high level of performance in their jobs.
  • Develops quality project plans. Coordinates projects. Communicates changes and progress. Completes projects on time and within budget.
  • Works closely with other functions to assure consistency and implementation of best practices.
  • Develops and oversees supply chain and vendor compliance programs.
  • Participates in computer system change management and system validation.
  • Provides support for internal and regulatory audits and inspections as required.
  • Collaborates with functional managers of departments to define, develop, deliver, and enhance cross-functional compliance traning.
  • Design, develop, and maintain GxP systems with the goal of 100% compliance.
  • Addresses, responds to, and completes CAPAs associated with compliance gaps.
  • Develops and implements processes and criteria to assess effectiveness of quality initiatives.
  • Arranges for periodic presentation of company quality metrics for management reviews, etc., as needed.
  • Other duties as assigned.

About you:

  • Bachelor’s degree in biological sciences or related field; Master’s degree preferred.
  • 10+ years progressive GxP compliance experience in a pharmaceutical or biologics operation; biologics or vaccines experience preferred.
  • Expert knowledge of multi-regional regulatory requirements; knowledge of computerized systems a plus.
  • Ability to read, analyze, and interpret standards, procedures, or governmental regulations/guidance.
  • Demonstrated consistent accuracy and thoroughness. Ability to apply feedback to improve performance. Monitors own work to ensure quality.
  • Strong organizational, management and cross-functional leadership skills.
  • Track record of effective collaboration, effectiveness in team settings, achievement of goals, and deliverables
  • Experience applying risk management principles to decision making.
  • Ability to write standard operating procedures, work instructions, reports, etc.
  • Experience with ICH, US and EU Regulatory Requirements.
  • Previous experience presenting and responding to regulatory agency audits.
  • Experience with auditing and inspections required.
  • Demonstrated ability to develop, coach, and mentor employees.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Ability to travel occasionally (US and International).
  • Ability to show confidence to lead and motivate employees to learn.
  • Demonstrate good judgement and escalate important issues to Sr. management; experience and comfort interacting with staff at all organizational levels required.
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise.
  • Ability to make independent sound decisions and independently manage priorities in alignment with department and site/global drivers.

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation