Senior Quality Assurance Operations Manager

Job Posted 6/4/2024
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Hercules, CA 94547
United States
Category BioTech
Job Description

Bio-Rad is seeking a Senior Quality Operations Manager to join our Northern California Product QA Team to support Global Supply Chain operations across multiple plants located in Northern California (NorCal). You will have 3-5 direct reports and responsibility for a total team of approximately 10-15 employees including QA Managers, Quality System Specialists and Quality Engineers. You will have responsibility for translating the company’s quality strategy into SOPs, tactical policies, processes, and procedures to always ensure compliance with meeting global regulatory standards across NorCal sites. The role is responsible for developing both short-term tactical objectives and execution plans in addition to longer term strategies to drive efficiencies through simplification of Quality processes and procedures while driving continuous improvement in manufacturing quality, product quality and compliance performance.


This includes activities such as: 



  • Product release and batch record review. 

  • Nonconforming product management. 

  • Function as Alternate Management Representative and PRRC (Person Responsible for Regulatory Compliance). 

  • Product & process transfer. 

  • Document and Record management. 

  • Process, equipment and software validation. 

  • Manufacturing and quality system related CAPA investigations. 

  • Internal/External/Regulatory audit support. 

  • Organizational & Resource Management.


How You’ll Make An Impact: 



  • Collaborate with other members of the Global Quality Assurance and Regulatory Assurance (QARA) organization and lead teams on the identification and standardization of best practices to drive both compliance excellence and process efficiency. 

  • Collaborate with Operations and Procurement leaders to identify potential areas of process and product variability, addresses root causes and implement improvements through the CAPA process to ensure the flow of quality products through the supply chain. 

  • Direct activities to ensure that all NorCal sites are in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that resources are sufficient, and projects are prioritized in alignment with regulatory requirements and business goals. 

  • Utilize data to assess the overall health and effectiveness of the Quality Operations processes/systems and identify areas for improvement. 

  • Lead strategy development at the site level and support the execution of a pipeline of continuous improvement initiatives to drive simplification, reliability, and overall effectiveness of Quality processes. 

  • Demonstrate knowledge of business impact of compliance issues and risk management.


What You Bring:



  • Education: Bachelor’s degree or equivalent in a related field. 

  • Work Experience: 6+ years’ experience in the Pharmaceutical, Medical Device, Biotech, or Life Science industry with a strong preference for leadership experience in a functional quality role.

  • Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, and GMP Operations, as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.

  • Working knowledge of FDA 21CFR Part 820 Quality Systems Regulations, ISO 13485 standards, MDSAP, and IVDR requirements.

  • Lead ISO auditor certification desirable. 

  • Skilled in statistical methods, statistical process control and sampling plans. 

  • Experience in project management and continuous improvement methodologies (e.g., Six Sigma, Lean, Total Quality Management) preferred.



Location: On site in Hercules CA


Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.​


 


Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance. 


 


Compensation: The estimated base salary range for this position is $169,800 to $225,000 at the time of posting.  Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.  This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance



Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.​


 


EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.


 


Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.  #LI-AK1


 




Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.
Employer