Quality System Manager

Abcam

Location: Fremont, California

Job Type: Full time

Posted


Company Description

From global research discoveries to clinical breakthroughs – our vision is to become the most influential life sciences company for researchers. If you are motivated by making a real impact to people’s life and have a desire to work in a passionate and diverse community, Abcam is the place for you.

Our culture is driven by our dedicated, agile and audacious community of professionals who are driven by a combined purpose and sense of belonging. We’re incredibly proud to be recognised as one of the top 5 best places to work in the UK for two years running, as per Glassdoor’s Employees’ Choice Award.

Job Description

Do you want to work for a business growing 20% year over year? Are you interested in overseeing a dedicated team? If the answer is yes, read on!

Due to our continuous growth, we are looking for a Quality Systems Manager to join our Manufacturing team. This person will work directly with manufacturing, logistics, and customer service teams across Abcam.

Your role will involve:

  • Assure the design control and manufacturing of the products are in compliance with the ISO13485 standard and Medical Device Regulations in the U.S., EU, Canada, and Australia
  • Manage the maintenance and integration activities related to the Quality Systems and responsible for continuous improvement of core quality systems to ensure optimization without compromising regulatory compliance
  • Provide assistance with internal team members, customer and regulatory audits, and identifying opportunities for implementation of continuous improvement
  • Manage direct report(s) for quality assurance, quality control and other operational functions
  • Lead root cause analysis and develop associated CAPA to prevent recurrence and ensure completion of effectiveness checks

Qualifications

You are someone who has practical experience in a Quality Assurance or Regulatory Department within a biotech, pharmaceutical, manufacturing, or similar environment that is FDA regulated. You have a strong understanding of what good, quality management systems look like as it relates to cGMP and can identify areas of improvement.

You are someone who will contribute to a healthy and safe working environment by adhering to health and safety regulations and company policies. You act in a responsible manner to ensure the care of your own health and safety and where appropriate, your team and that of others who may be affected by omissions at work.

If this sounds like you and you’d like to be part of a fast-paced, growing business with the vision to become the most influential company and best-loved brand in life sciences, please apply now!

Additional Information

We know that when it comes to benefits, no one size fits all. Flexibility and choice matter which is why we offer all kinds of ways to enable you and your loved ones to be well and live well. You can expect;

  • A culture focused on well-being and opportunities for growth and development. We provide a wide range of training opportunities, for both professional and personal development.
  • The freedom to work in a way that works for you, with a focus on maximizing productivity and innovation at work while reducing environmental impact.
  • A performance-based share plan, inspiring and rewarding our people as we deliver Abcam’s strategy.
  • Attractive and flexible benefits package including 18 weeks full paid maternity leave and 6 weeks full paid paternity leave, increased paid time off accrual over time and much more.

We offer a truly inclusive environment where you can bring your whole self to work. This is underpinned by our Employee Resource Groups (ERGs) and our partnerships with WORK180 (endorsed employer for women) and MyGwork (LGBT+ professional community). All our positions are open as a Job Share, where two talented professionals can share the responsibility of a full time position. You can declare your interest in a job share role within the application form.

Abcam is an Equal Opportunity Employer and makes all employment decisions without regard to age, national origin, race, ethnicity, religion, creed, gender, sexual orientation, disability, veteran status, or any other characteristic protected by law.

If you’re interested in this particular role then we’d love to read your application.

Effective January 1, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Abcam. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.

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