Senior Director, Quality Assurance

Location
San Diego, CA, United States
Posted
Jan 27, 2021
Ref
ohfxefw1
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Company Overview

At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.

Job Summary

We are seeking a Senior Director of Quality Assurance who is experienced, highly energetic, and committed to robust collaboration to achieve important Quality Assurance metrics. This individual will lead the development and implementation of optimized GxP quality systems as well as provide QA and compliance oversight. This individual will provide operational and strategic input to cross-functional teams and ensure effective communication and constructive working relationships with colleagues and business partners to enable global development of Avidity therapeutics. The Senior Director of Quality Assurance will report directly to the Senior Vice President of Regulatory Affairs and Quality Assurance.

Essential Duties and Responsibilities

  • Establish and maintain the GxP quality systems in a fast-moving, entrepreneurial organization to support pharmaceutical development, clinical studies, and future product registration
  • Provide QA and compliance oversight for Avidity supply chain and development activities, including supporting site identification and site qualification, audits of vendors, suppliers and contract manufacturers, and creation of quality agreements
  • Represent the Quality function to executive management and external partners
  • Oversee GxP related activities at external contract research and manufacturing organizations
  • Oversee batch record review and batch disposition
  • Partner and align across the organization to develop and implement strategies to drive organizational success
  • Provide strategy QA input to company's product development goals, including quality audit plans and budgets
  • Identify and communicate Quality or compliance risks and participate in developing appropriate plans to address
  • Develop and approve Quality Agreements with GMP vendors
  • Establish and maintain phase appropriate risk management and change control systems from early development through commercialization
  • Ensure appropriate document management systems
  • Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
  • Trend performance of the Quality Management System and provide metrics to senior management for review on a regular basis
  • Build a strong Quality Assurance organization through hiring and staff development
  • Develop, implement and oversee training programs to ensure compliance with GxP and ICH requirements


Qualifications
  • Minimum Bachelor's degree in a relevant scientific discipline such as chemistry, biology, or pharmaceutical sciences
  • Minimum of 8 years of pharmaceutical industry experience in Quality Assurance and Quality Control/ Manufacturing/Technical Operations or other relevant development functions
  • Extensive knowledge of cGMP, ICH, FDA, EMA guidelines and requirements across development, registration and validation
  • Good working knowledge of GLP and GCP guidelines in support of non-clinical and clinical study conduct
  • Proven track record in GxP risk assessment and phase appropriate quality risk management
  • Proven track record of effective collaboration with external manufacturing and research organizations
  • Proven ability to thrive and enable success in a cross-functional and collaborative environment
  • Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving
  • Ability to multi-task, manage conflict, and work in a fast-paced environment