Associate Director, QA Sterility Assurance

4 weeks ago

Durham, United States Lonza Full time
United States, Portsmouth (New Hampshire)

Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents.

Join Lonza AG as an Associate Director, QA Sterility Assurance - LSA, and become part of an outstanding team dedicated to hardworking and flawless execution in life sciences. This outstanding opportunity allows you to craft the sterility assurance program within our ambitious and rapidly growing healthcare manufacturing organization. Be at the forefront of innovation and quality as we continue our world-class operations across five continents.

Key responsibilities:

  • Provide QA oversight of Aseptic Processing Program, Environmental Monitoring, and Microbial Control Policies for Cell Therapy and Viral Therapy Operations.
  • Independently review and approve policies, procedures, and completed media fill/APS documentation.
  • Coordinate Environmental Monitoring sample plans, cleanroom qualifications, and manage environmental monitoring excursions, deviations, and sterility failures.
  • Conduct reviews of sterile filter validations and integrity testing procedures.
  • Collaborate closely with Cell and Viral Therapy Operations Management, as well as QC and QA leadership, to ensure strict adherence to sterility assurance standards.
  • Maintain sterility assurance for aseptically manufactured sterile drug products and viral vector products, ensuring they meet the highest quality and regulatory standards.

Key requirements:

  • Bachelor's Degree in life sciences field.
  • 7-10 years of experience in QA oversight within a similar role.
  • Proven ability to work independently with minimal direction.
  • Strong analytical skills to determine and successfully implement effective sterility assurance strategies.
  • Excellent communication and collaboration skills to interact with cross-functional teams and ensure seamless operations.
  • Dedication to upholding world-class standards in sterility assurance and quality control.

This is an outstanding opportunity to join a team dedicated to making a significant difference in the life sciences industry. At Lonza, your contributions will help us continue to deliver high-quality healthcare solutions that have a positive impact on millions of people globally. Apply today and take the next step in your career with a company that values innovation, integrity, and excellence.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R63587

  • QA Analyst

    4 weeks ago

    Durham, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. Join Lonza AG as an Associate Director, QA Sterility Assurance - LSA, and become part of an outstanding team dedicated to hardworking and flawless execution in life sciences. This outstanding...

  • QA Analyst

    3 weeks ago

    Durham, NH, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents. Join Lonza AG as an Associate Director, QA Sterility Assurance - LSA, and become part of an outstanding team dedicated to hardworking and flawless execution in life sciences. This outstanding...

  • Sterile Processing Director

    6 days ago

    Durham, North Carolina, United States Duke Health Full time

    Sterile Processing Director Opportunity at Duke HealthAchieve a Career of Excellence in Sterile ProcessingAs a Sterile Processing Director, you will play a vital role in ensuring the highest standards of sterilization and infection control within our esteemed healthcare institution. With a strong focus on minimizing environmental cross-contamination and...

  • Senior QA Technical Specialist

    6 months ago

    Durham, United States Fujifilm Corporation Full time

    Overview We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine...

  • Sterile Processing Manager

    2 months ago

    Durham, United States Duke University Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.About Duke University HospitalPursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    2 months ago

    Durham, United States Dukehealth.org Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.About Duke University HospitalPursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    4 weeks ago

    Durham, United States Dukehealth.org Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    1 week ago

    Durham, United States Duke Health Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    2 weeks ago

    Durham, United States Duke Health Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    1 month ago

    Durham, United States Duke Health Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    1 month ago

    Durham, United States Dukehealth.org Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    6 months ago

    Durham, United States Duke Health Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Manager

    3 months ago

    durham, United States Duke Health Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Senior Data Engineer and QA Automation Specialist

    4 weeks ago

    Durham, North Carolina, United States Fidelity TalentSource LLC Full time

    Job SummaryWe are seeking a highly skilled Senior Data Engineer and QA Automation Specialist to join our Workplace Investing Quality Engineering team at Fidelity TalentSource LLC.About the RoleThis exciting new role within the Workplace Investing (WI) Data Engineering space requires a senior-level professional with expertise in designing, developing, and...

  • Sterile Processing Supervisor

    2 months ago

    Durham, United States Duke University Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.About Duke University HospitalPursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Supervisor

    4 weeks ago

    Durham, United States Duke University Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Supervisor

    1 month ago

    Durham, United States Dukehealth.org Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Sterile Processing Supervisor

    1 month ago

    Durham, United States Dukehealth.org Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.About Duke University HospitalPursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Pharmacy Sterilization and Compounding Expert

    8 hours ago

    Durham, North Carolina, United States Triangle Compounding Pharmacy Full time

    Pharmacy Sterilization and Compounding ExpertWe offer a competitive salary of $45,000 - $60,000 per year based on experience and a family-oriented work environment with benefits including:Fully paid health insurance401K planPTO and holiday time offAs a sterile compounding pharmacy technician at Triangle Compounding Pharmacy, you will play a key role in...

  • Sterile Processing Supervisor

    2 weeks ago

    Durham, United States Duke Health Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. About Duke University Hospital Pursue your passion for caring with Duke University Hospital in Durham, North Carolina,...