Director of Quality Assurance and Regulatory Affairs, Molecular Diagnostics & Life Sciences

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Position and Scope

This position reports to the Chief Operating Officer and will be responsible for leading Quality Assurance for the Molecular Diagnostics & Life Sciences business segment of Argonaut Manufacturing Services. This individual will be a hands-on Director overseeing the review and disposition of raw materials and final goods. They will be responsible for coordination with all departments to ensure that timelines are met. In addition, this position will be responsible for improving quality systems, processes, and procedures to increase the overall level of compliance within the Molecular Diagnostics & Life Sciences group.

General Responsibilities

  • Actively work with Manufacturing to solve challenges in the production environment
  • Lead external agency inspections and client audits relating to Molecular Diagnostics & Life Sciences, ensuring compliance with policies, procedures, and regulatory requirements
  • Resolve day to day issues within functional departments and provide compliance assistance, as needed
  • Develop and approve Quality Agreements with clients and suppliers
  • Facilitate the investigation, reporting and closure of quality events, including CAPAs, customer complaints, deviations and non-conformances
  • Assist in supplier audits, including participation in assessments for supplier qualifications
  • Review and approve qualification and validation protocols and reports for equipment and processes related to Molecular Diagnostics & Life Sciences products
  • Lead and assist in performing all tasks necessary to achieve the organization’s mission and help execute growth
  • Represent Quality Assurance on project teams and support and participate in new project transfers
  • Ensure continuous improvement and effectiveness of the quality management system
  • Build strong working relationships with clients to enhance and ensure quality awareness
  • Oversee batch record review and batch disposition
  • Build a strong Quality Assurance organization through hiring and staff development

Specific Skills

  • An extensive knowledge of cGMP, ISO, and FDA Regulations, specifically 21 CFR – Part 820, ISO 13485, and ISO 14971
  • Ability to effectively organize, multi-task, manage conflict and work in a fast-paced, timeline driven work environment
  • 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
  • Desire to work with all departments to implement change
  • Detail-oriented with the ability to troubleshoot and resolve problems
  • Ability and willingness to work flexible/extended hours, if needed
  • Excellent oral and written communication skills and listening skills

Position Requirements and Experience

  • Minimum Bachelor’s degree in a relevant scientific discipline such as chemistry, biology or pharmaceutical sciences
  • Successfully served in a similar capacity in a contract manufacturing company for a highly regulated market, preferably the life science/pharmaceutical environment
  • At least 10 years’ work experience in a Quality field for GMP company with at least 5 years management experience
  • Experience and familiarity in reagent formulation, filling and finishing activities with several years of directly related accountability for quality in this form of manufacturing
  • Experience and expertise in communication exchanges with clients during tours, meetings, and audits
  • Consistently exhibit through actions, decisions, and interactions (internally and externally), the highest standards of ethics and integrity
  • A “hands-on” management style with the interpersonal skills required to build a successful team and the desire to motivate, inspire and develop team members
  • The ability to create, direct and implement corporate objectives in an environment with a high sense of urgency
  • A track record of recruiting exceptional talent within the economic constraints of a small company
  • A proactive style using initiative and perseverance in order to bring about meaningful change
  • Familiarity with Lean Manufacturing cultures in a volume production facility

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

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