Associate Director QA

Company: Ferrer Internacional SA
Location: Fremont
Posted on: April 1, 2025

Job Description:

The Associate Director, QA will report to the Senior Director, Quality Assurance performing activities in support of clinical and commercial manufacturing and testing, design and development projects, as well as establishing and maintaining a quality management system that is compliant to FDA, ISO and EU requirements and assisting in QA oversight of validation activities including facility, utility, manufacturing processes and analytical methods.Responsibilities

• Direct Quality Assurance Operations and Systems group to execute on quality processes for both commercial and clinical products manufacturing, testing and design development.
• QA Operations:
  • Oversee the materials and product lot release for clinical and commercial products assuring data integrity compliance to internally and externally executed data and records.
  • Manage all eQMS records such as NCR, CAPA or change controls associated with product manufacturing, analytical testing and other GMP activities.
  • Track and trend quality process data; lead discussions on trending analysis of key quality indicators and/or key process indicators.
  • Lead cross functional teams in data collection and evaluation of commercial products and deliver product quality review report annually.
  • Chair Quality Review and Material Review Board meetings as needed.
  • Support QA oversight of critical suppliers and partners.
  • Support QA oversight of validation activities including but not limited to equipment, facility/utility, automation systems, computerized systems, and manufacturing processes.
  • Lead cross functional team to complete revalidation assessments activities for Fremont site.
  • Work on issues of diverse to complex scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business and regulatory trends.
  • Quality Systems:
    • Lead the maintenance and enhancement of quality management systems and related activities including NCR/CAPA process, Change Control, Document Management, Quality procedures, Product Complaint Program.
    • Administer eQMS and maintain the DOT Compliance System.
    • Support audit activities during GMP inspections and partner audits.
    • Support and promote audit readiness.
    • Track and Trend Quality Objectives and key metrics related to quality records.
    • People Management:
      • Mentor staff and develop a highly functioning QA team.
      • Develop and maintain productive working relationships with Manufacturing Operations, Facilities, Device Development, Product R&D and Quality Control departments.
      • Manage direct employees assuring Alexza project timelines and day-to-day QA operations are maintained.Skills Required:
        • Comprehensive knowledge of cGMP regulations (US and EU).
        • Excellent verbal and written communication skills.
        • Strong organizational and prioritization skills to handle multiple priorities in a fast-paced environment.
        • Strong leadership ability, both within department and in cross-functional team settings.
        • Ability to maintain a flexible and customer-oriented approach to problem-solving.
        • Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results.
        • Ability to make tough decisions and ability to influence project deadlines and quality outcomes.
        • Ability to maintain detailed and accurate records.
        • Familiarity with electronic Quality Manage Systems, (DOT compliance, Veeva, Trackwise etc)Education and experience
          • BS in scientific or related discipline.
          • Minimum 10+ years cGMP experience in Quality Assurance.
          • Knowledge and understanding of combination pharmaceutical/device product 21 CFR 3.2(e), CFR 210 / 211, CFR 820, ISO 13485, European pharma and device regulations.
          • Experience in Quality Systems, Validation and/or risk Management in the medical device, pharmaceutical, biologics or combination products industry are preferred.
          • Proficient in the use of a wide variety of computer applications including the MS office, Excel, database management systems, project management software, ERP software, and Quality Systems software (Veeva, DOT, Trackwise etc.)
          • Experience with Health Authority or FDA inspections is preferred.Physical Requirements
            • Prolonged periods of sitting at a desk and working on a computer.
            • Potentially prolonged periods standing.
            • Must be able to lift up to 15 pounds at times.
            • Must be willing to travel.CompensationThe annual base salary for this role starts at $200,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. The initial base salary is just one component of Ferrer's total compensation and benefits package, which includes, but is not limited to, discretionary bonus plan; life, health, accident and disability insurance; and a 401(k) plan.Who we areAt Ferrer we are a group of people who believe in the power of purpose. And our purpose is to make a positive impact in society and bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace. We reject greenwashing and empty promises - we are about action. That is why in 2022 we became a B Corp company.Alexza Pharmaceuticals is part of Ferrer and is an R&D and Manufacturing center located in Fremont, CA. Our focus is to develop technologically advanced, forward-thinking and innovative products for our pipeline based on the Staccato One Breath Technology. We research, develop and manufacture novel, proprietary products for the acute treatment of underserved medical needs.Why Alexza/Ferrer
              • Make a positive impact in society
              • Grow in a culture of trust, responsibility, and constructive feedback
              • Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
              • Make a real difference to the team and to yourself
              • Take advantage of opportunities for development & learning
              • Discover a range of benefits to support your physical, emotional and financial wellbeingRequirementsWhat you'll need to succeedWe believe that a combination of benefits and unique career development programs allows our dedicated professionals to thrive in a culture where collaboration and creative thinking are the order of the day. You will rock at our company if you are a person that connects with our values: empathy, humility, curiosity and optimism in addition to the following qualities:
                • You are a purpose and value driven person
                • Have outstanding people skills
                • Have excellent communication skillsIf you're looking for diverse challenges, then we are waiting for you!Alexza/Ferrer is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.Sector: Pharmaceutical and biopharmaceutical
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Keywords: Ferrer Internacional SA, Fremont , Associate Director QA, Executive , Fremont, California