Director, GMP Quality Assurance

Location
San Diego, California
Posted
Jan 12, 2022
Ref
oY5bifwg
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Company Overview

 Avidity Biosciences 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 therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Summary

The Director, GMP Quality Assurance, reporting to the Head of Quality Assurance, will lead the GMP quality function by supporting and providing oversight of CMC activities, establish and manage GMP quality systems, and ensure GMP compliance. The candidate will be a hands-on and actively involved in executing GMP QA strategy, collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues and business partners to enable global development of Avidity therapeutics.

Essential Duties and Responsibilities
  • Develop, implement, and maintain GMP quality management systems, policies, and SOPs
  • Ensure GMP compliance of manufactured drug substance, drug product, labeling, and packaging of clinical materials
  • Conduct review of MBRs and EBRs and perform final product disposition
  • Perform quality management review and approval of Deviations, OOSs, Change Controls, CAPAs and any other related quality records
  • Review and approve product specifications, test methods, qualification/validation protocols and reports
  • Identify compliance risks, perform risk management, and implement risk mitigation, as applicable.
  • Monitor, track, and trend GMP quality systems and establish metrics
  • Manage GMP audit activities, including conducting vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out audits
  • Manage investigational product complaints and are investigated to ensure compliance
  • Establish inspection readiness program
  • Manage GMP training and provide quality training as appropriate
  • Perform other duties as required

 Qualifications

To perform this role successfully, an incumbent must be able to perform each essential duty satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 Preferred Education and/or Experience:

  •  Minimum Bachelor’s degree in a relevant scientific discipline or equivalent
  • Minimum of 8 years of pharmaceutical industry experience in CMC/GMP QA
  • Extensive knowledge of GMP regulations, ICH Guidelines, FDA regulations and Guidance
  • Good knowledge or experience in Aseptic processing
  • Experience in monoclonal antibodies and/or biologics is a plus
  • Experience working with CMOs, vendor selection, and management
  • Proven ability to thrive and enable success in a cross-functional and collaborative environment
  • Strong communication and interpersonal skills (maintain positive relationship and open communication)
  • Ability to multi-task, shift priorities, and work in a fast-paced environment
  • Detail oriented and well organized
  • Team player, professional demeanor, enthusiastic, and self-motivated
  • Travel 15-20%, as required