Manager, Quality Assurance

Posted 12 Hours Ago
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San Diego, CA
Senior level
Healthtech • Pharmaceutical
The Role
The Manager of Quality Assurance at ARS Pharmaceuticals leads quality assurance operations, ensuring compliance with regulatory standards, overseeing batch record reviews, and managing quality systems for commercial suppliers. This role includes conducting external audits, mentoring staff, and supporting regulatory inspections and submissions.
Summary Generated by Built In

ARS Pharmaceuticals is a commercial pharmaceutical company, passionate about improving patients’ lives.  We are launching neffy®, an intranasal epinephrine product for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. We promote a culture of inclusivity, integrity, and creativity, while pursuing solutions for patients and families affected by serious allergic reactions. 

JOB SUMMARY:

The Manager, Quality Assurance is responsible for managing the oversight of quality operations at commercial service providers of API, device component and Drug Product, packaging and distribution to ensure that vendors are in compliance with applicable regulations (e.g. cGMP), and Quality Agreement (s), and relevant Standard Operating Procedures (SOP’s). 

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls to ensure that performance and quality of commercial suppliers conform to established standards and regulatory agency requirements;
  • Primary person for the oversight of master batch record review and approval, executed batch record review, assessment of deviations, change controls and analytical data;
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance;
  • Works directly with commercial suppliers to ensure that operations remain in a compliant state, and product meets all required standards and specifications; specifically, managing commercial change control, lot disposition, quality investigations and CAPA closures;
  • Quality oversight responsibilities from validation to commercial scale up;
  • Supports or leads external commercial quality audits, and supports ARS during CMO site inspections by regulatory agencies;
  • Responsible for Annual Quality Review and supporting regulatory submission;
  • Ability to work collaboratively and independently with commercial and development product manufacturing teams, business partners, CMOs and vendors;
  • Manages and mentors Quality staff.

EDUCATION AND EXPERIENCE:

  • Bachelor’s degree in science or related fields and 8+ years of relevant experience in a highly regulated manufacturing environment;
  • In-depth knowledge of QA principles, concepts, industry practices, standards, computer systems validation and ICH Guidelines;
  • Knowledge of performance measures and quality improvement statistical tools; 
  • Demonstrated ability in exercising superior judgment and working independently with minimal supervision and/or guidance;
  • Effectively adopt systematic approaches in order to maximize efficiencies and scalability;
  • Ability to manage tasks with competing priorities or deadlines;
  • Ability to understand / implement written and verbal instructions to all levels of the organization; including presenting in small groups;
  • High level of professionalism and collaboration in team settings;

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Extensive experience working successfully with vendors, CMOs and leading a staff;
  • Ability to travel up to 20%, depending on business needs;
  • Fit with ARS culture and values.

 

At ARS, we are proud to offer a highly competitive compensation & benefits package. 

 

The full-time salary range for this posted position is $135,000 to $150,000 and may be eligible for a discretionary annual performance bonus. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law.


This position is also eligible for Equity, 401k matching, and our excellent benefits package including 100% employer paid Medical, Dental & Vision for employees. View the full package here: ARS Careers Page

ARS Pharmaceuticals believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. ARS Pharmaceuticals is also committed to providing reasonable accommodation to qualified individuals so that an individual can perform their job-related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected]

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

The Company
San Diego, CA
128 Employees
On-site Workplace

What We Do

Our mission at ARS Pharmaceuticals is to provide at-risk patients and their families better protection from severe allergic reactions. We are developing a product that patients and their caregivers can use without anxiety or hesitation, confident in the effectiveness of the both product and the ability to administer it.

We are developing ARS-1, a novel intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, convenient and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis

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