Description
Job Title:
Document Control Manager
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Regulatory Affairs & 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™). 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. 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 Document Control Manager, reporting to the Associate Director, Document Management and Training, will assist in the daily management of document control and training program activities to ensure GxP compliance.
The candidate will be hands-on for processing and maintaining GxP quality management systems documents and records, implementation and management of an electronic document management system (EDMS/LMS/QMS), periodic review of SOPs and archival of quality records, and maintaining the GxP training program, including new hire onboarding.
What You Will Contribute

• Maintain company's eDMS, LMS, and eQMS, and serve as backup System Administrator to assign access and tasks.
• Assist with eDMS/LMS /eQMS system implementation and the development of user training materials, including SOPs, and support initial and ongoing validation activities.
• Process and maintain GxP controlled documents including the management of new/revised SOPs.
• Perform routine Document Control duties independently, including processing QMS documents, formatting documents, routing/tracking document review and approval, and issuing effective documents.
• Assist with GxP Training for new/existing employees, and establish and maintain employee training files, including on-boarding/off-boarding.
• Assist with establishment and maintenance of GxP employee training curriculum records and ensure compliance to established SOPs and regulations.
• Compile and report Document Control and Training metrics for management review.
• Assist with document periodic review process and document archival.
• Perform other duties and complete special projects as required.
• Effectively collaborate in a highly matrixed organization

What We Seek

• Minimum of Bachelor's degree in a relevant scientific discipline or equivalent.
• Minimum of 5 years of pharmaceutical industry experience in biopharma document management.
• Experience in EDMS administration and 21 CFR Part 11 compliant software systems. Veeva Vault proficiency is preferred.
• Experience in managing and maintaining Document Control systems and GxP training programs.
• Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections.
• Strong written and verbal communication and interpersonal skills.
• Commitment to supporting internal and external teams and customers.
• Meticulous attention to detail and well organized.
• Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems.
• Collaborative team player, professional demeanor, enthusiastic, and self-motivated.
• Ability to travel to the San Diego office 3-4 times per year.

What We will Provide to You:

• The base salary range for this role is $132,100 - $146,100. 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