Quality Control Manager II

The Quality Control Manager position will manage the Quality Control Department and oversee and direct all site activities for customer related quality processes, such as audits, complaint resolution, and visits, for the Richmond Chemical Plant that produces process chromatography resins, liquid buffers, monomer solutions, oils, and other specialized life science products. In this role, you will be key to safely and efficiently meeting the current and future manufacturing commitments for a growing, key business for Bio-Rad and to ensure continued strong relationships with our customers. As part of the Site Leadership Team, you will work closely with other site leaders and with key stakeholders in R&D, Product Management, and Quality Assurance to ensure we successfully manufacture products that meet predetermined specifications and quality attributes. 

In this role, you will manage a department with 5-7 specialists and be responsible for the day-to-day quality control testing of raw materials, intermediates and finished products to a range of specifications. The QC laboratory includes HPLCs, GCs, FTIR, Horiba, Particle Size Analyzers, Porosimeter, Spectrophotometers, Densitometers, Auto-titrators, and other testing equipment. Alongside the day-to-day quality control requirements, you will be the site interface in customer facing programs and you will also take a lead role in the change management processes.

How You’ll Make An Impact:

• Act as primary site contact for Quality Notifications (QNs), Non-Conformance Reports (NCRs), Customer Complaints and Corrective Action Preventive Actions (CAPAs) and drive to completion partnering with Technical Service. 
• Develop and monitor quality control and customer metrics, including control charts, and report out to various groups and in various meetings. 
• Day to Day management of Quality Control laboratory ensuring internal and external customer needs are met, and priorities are routinely reviewed and adjusted as needed. 
• Defines and specifies the implementation of standards, methods and procedures for testing and evaluating the precision, accuracy and reliability of company products. Manage ongoing collection, analysis and communication of QC data. 
• Conduct Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEAs) and develops fishbone analysis, control charts, and capability studies to define QC specifications and investigate product complaints and Out of Box failures (OBFs). 
• On behalf of Quality Control department, develop Installation Qualification (IQ), Operation Qualification (/OQ/ and Performance Qualification (PQ validation plans and reports and actively participate in New Product Introductions (NPIs) 
• Implement continuous improvement culture in Quality Control department and continual develop QC personnel skills.

What You Bring:

• Education: Minimum requirement is a Bachelor’s degree in Chemistry or closely related equivalent. Advanced Degree preferred. 
• Work Experience: 10+ years quality control experience in a complex manufacturing environment and/or direct chemical manufacturing experience. 
• 8 + years of supervisory experience. Preference given to candidates who have managed Quality functions as well as Quality Control functions. 
• Demonstrated excellent technical and analytical skills in a complex chemical manufacturing or laboratory environment. Experience with multiple machines including HPLCs, NMR. 
• Strong communication, public-speaking, decision-making, MS Office, and negotiation/persuasion skills. Ability to communicate effectively and professionally to internal and external customers in written format and verbally via in person/online meetings and as part of presentations.
• Previous experience with external customers as part of audits, qualifications or complaints resolution. Strong customer orientation and focus. 
• Thorough understanding of ISO 13485 is a requirement. Experience/strong understanding of GMP practices is also highly desirable. Knowledge of chemical/biotech manufacturing processes and how quality programs impact them is preferred. 
• Proven experience in managing Quality Programs, Customer complaints, or non-conformance management is a requirement. 
• Familiarity with SAP or similar ERP systems is a plus. 
• Continuous Improvement/Lean/TPM experience is desirable.

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, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more! 

Compensation: The estimated base salary range for this position is $153,100 to $210,600 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. 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.

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