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Director, Quality Systems and Compliance

Employer
Avidity Biosciences
Location
San Diego, California
Start date
Nov 3, 2024
View more categoriesView less categories
Discipline
Quality, Quality Control, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach

Job Details

Job Title:

Director, Quality Systems and Compliance

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Regulatory and Quality Assurance

Strive to Bring a Profound Difference to our Patients

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.

The Opportunity

The Director, Quality Systems and Compliance is a senior leader accountable for the quality oversight and compliance support of the GxP quality systems and ensuring continuous process improvement within the Quality Assurance department.  This position will also be responsible for the management and support of inspection readiness program. The candidate will be hands-on and strategic for ensuring the quality systems, enable and facilitate compliance with applicable regulations (FDA, EU and other countries) and company’s policies and procedures.

What You Will Contribute

  • Develop, improve, and implement risk-based and appropriate quality management systems, policies, and procedures in support of GxP work.
  • Lead the quality systems changes, new initiatives, and process improvement to support evolving regulations and international standards.
  • Ensure regulation compliance of quality systems across GxP activities including review and approval of quality documents and continuous improvement.
  • Collaborate with cross-functional teams to ensure alignment on quality objectives and priorities.
  • Establish and manage the performance and effectiveness of quality systems and processes; SOPs, deviations, CAPA, change control, investigations, audits, and training.
  • Develop quality metrics, including trending and reporting data for Management Reviews.
  • Collaborate with internal and external teams in addressing quality compliance events and proactively identify and mitigate issues.
  • Support the implementation of electronic QMS.
  • Identify compliance risks and implement risk mitigation plans to enable innovative solutions.
  • Develop inspection readiness program, mock inspections, and support and participate in regulatory authority inspections.
  • Establish or support Quality Agreements with applicable contractors.
  • Support GxP vendor qualification activities and audit program.
  • Perform other duties as required.

What We Seek

  • Minimum a bachelor’s degree in a relevant scientific discipline or equivalent
  • Minimum of 10 years of pharmaceutical industry experience in QA with extensive knowledge of Quality Management Systems.
  • Exhibit leadership conduct with high standards, professionalism, and ethics.
  • Implementing phase appropriate and commercial quality systems.
  • In-depth knowledge of GxP regulations and Guidance (FDA, EU, ICH).
  • Experience in regulatory inspections and inspection readiness.
  • Experience working with Contract Service Organizations.
  • Proven ability to thrive and enable success in a cross-functional and collaborative environment.
  • Ability to multi-task, shift priorities, work in a fast-paced environment, and problem-solving.
  • Detail oriented, well organized, and strong project management skills.
  •      Team leadership experience within a cross-functional matrix environment.
  •      Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
  •      Ability to travel as needed for 10%.
 What We will Provide to You:
  • The base salary range for this role is $196,900 – $217,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
  • Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
  • A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901

 

Company

avidity banner

Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics. We’re utilizing our proprietary AOC platform to design, engineer, and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) with the precision of oligonucleotide-based therapies in order to redefine RNA therapeutics and more effectively target underlying genetic drivers of diseases. We are delivering on this vision by investing in our platform, our pipeline and our people.

Our commitment to rigorous and innovative science is matched only by our passion to see patients’ lives changed. We consistently challenge ourselves to Be AVID – Agile, Visionary, Integrated and Diverse.

We are assembling a diverse team experienced in rare disease and RNA therapies. Our team members bring expertise in research, development and commercial execution. We are focused on cultivating the right team to not only grow the company, but also to reflect the communities we serve. We are dedicated to employing and retaining a diverse and inclusive workforce at all levels of the organization to not only ensure that different backgrounds and perspectives are being heard and acted upon, but that our employees also feel understood, accepted and valued.

 

be avid

avidity team 3 avidty team 2

avidity team

Company info
Website
Phone
858-401-7900
Location
10578 Science Center Drive
Suite 125
San Diego
California
92121
US

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