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Quality Manager - IVD

Department: Quality & Operational Excellence

Location: Burlingame, California, United States

About the role 

This position manages daily quality assurance activities within the IVD department. and will work directly with validation project scientists, manufacturing personnel, logistics and customer service personnel and management to assure the implementation of quality management.  Performs and maintains critical quality systems (e.g., ISO13485, FDA Quality System Regulation, non-conformances, corrective and preventative actions, investigations, training, and metrics) as they relate to the manufacture, analytical testing, and auditing of internal and external quality assurance related activities.

 

Roles & responsibilities:

The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned.  Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

  • Assure the design control and manufacturing of the products are in compliance with  FDA Quality System 21 CRF, Part 820) and ISO13485 Regulations.
  • Manage the maintenance and integration activities related to the Quality Systems, providing assistance with internal team members, customer and regulatory audits, and identifying opportunities for and implementation of continuous improvement. Responsible for continuous improvement of core quality systems to ensure optimization without compromising regulatory compliance.
  • Provide hands-on ownership for the various elements of the quality system to ensure successful performance during third-party audits and regulatory inspections.
  • Lead and manage Quality investigations.
  • Provide support to internal functions in the application, maintenance and improvement of quality systems and department specific procedures.
  • Lead root cause analysis and develop associated CAPA to prevent recurrence and ensure completion of effectiveness checks.
  • Lead the program for developing and justifying meaningful quality system metrics and provide regular updates to Quality management.
  • Initiate updates and creation of new functional SOPs as required.
  • Serves as Quality representative for Quality System audits and regulatory inspections as needed.
  • Manage some operation related projects (e.g.. customer service and  external collaborations) .
  • Manage direct report(s) for quality assurance and other operational functions (e.g., customer service).
  • Comply with all safety and quality standards.
  • Manage regulatory related affairs as needed in territories that the products are sold.
  • Manage regulatory compliance issues and communication with regulatory bodies in US and outside of US
  • Employees must contribute to a healthy and safe working environment by adhering to health and safety regulations and company policies. Employees must act in a responsible manner to ensure the care of their own health and safety and where appropriate, their team and that of others who may be affected by their omissions at work
  • While performing the duties of this job, the employee is frequently required to do the following: Sitting, using a computer & Lift 5-10 lbs occasionally
  • Office Setting 90%
  • Occasional Travel for Professional Conferences 10%
  • Exposure to toxic/hazardous/dangerous chemicals.

 

About you

  • Bachelor’s Degree in biochemistry, pathology, cell and molecular biology, immunology or other Life Sciences required; Master’s Degree preferred.
  • Minimum 3 years of industrial working experience under ISO 13485 or FDA QSR is required. Experience in establishing and implementing above mentioned quality system is a plus.
  • Experience in administering quality management systems such as US FDA QSR (21 CFR: 820)  ISO 13485:2016 is preferred
  • Familiarity with IVD immuno-assay product development process such as design control and IVD product manufacturing.
  • Understanding of immunohistochemistry (IHC) products for anatomic pathology application is a plus.
  • Excellent working knowledge and understanding of GMP-related requirements and proficiency of regulatory guidelines with the ability to assess risk.
  • Working knowledge of developing and establishing quality indicators and metrics.
  • Detail oriented with quality assurance background with solid problem solving acumen.
  • Ability to work effectively in a team environment with great organization skills.
  • Excellent working knowledge of Quality Systems and cGMP standards applicable to assay product development process.
  • Ability to analyze and reconcile moderate to complex issues independently.
  • Must be an individual with proven initiative and demonstrated accountability in a fast-paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with Microsoft Office

If this sounds like you and you’d like to be a 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!

 

About Us

Ever since 1998, when our founder, Jonathan Milner, started selling antibodies from the back of his bike, Abcam has aimed to help scientific researchers make breakthroughs faster. We now have offices and labs in the UK, the US, China and Japan, and as we continue to grow, we remain ambitious, driven by our customers’ success and their research needs.

It’s our goal to provide a world-standard in protein research tools, technical support and delivery. When you join Abcam, you’ll join a global business with the passion and the vision to become the most influential company, and, best-loved brand in life sciences.

Our culture is our key differentiator. We believe in empowering individuals, with responsibility given at an early stage. The working environment is fun and fast-paced, collaborative and outcome focused, with a strong customer focus. In addition to competitive salaries, we can offer an attractive flexible benefits package which includes share options, a culture focused on well-being and opportunities for growth and development.

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.