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Senior Manager, QC

Location: San Jose, CA, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

Company Overview:

bioMrieux is a medical device company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST directly from positive blood cultures. Our mission is to provide innovative and reliable medical devices that improve patient outcomes and enhance the life of people around the world. Our team of highly skilled professionals is dedicated to excellence in research, development and manufacturing.

Primary Duties
1. Oversees microbiological, chemical, and physical inspection testing functions. Recruits and develops team members, establishes resources and determines actions necessary to accomplish quality control objectives.
2. Reviews and approves test results. Supports release of final product, raw materials, components, and intermediate products. Supports ongoing product stability testing.
3. Develops and implements departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, CLIA, OSHA, etc.). Ensures department adherence to established procedures.
4. Ensures timeliness and efficiency of product and material testing to meet production demands and promotes continuous improvement of departmental performance.
5. Initiates and completes OOS, NCMR, and CAPA investigations as required. Supports and participates in internal and external audits.
6. Ensures that all lab instruments are appropriately validated, calibrated and monitored for compliance. Reviews records for compliance per procedures and regulations.
7. Communicates the quality status of materials and processes to internal customers.
8. Develops and maintains regular Quality Control metrics. Trend and report metric data to communicate the effectiveness of current processes, test methods, and personnel performance.
9. Develops and maintains annual departmental budget plans.
10. Maintains environmental monitoring program compliance.
11. Works with other departments to ensure operational and quality goals are understood and met.
12. Supports review of customer complaints. Participate as needed on special teams and/or projects.
13. Leads team members by clearly establishing performance expectations, providing adequate training and resources, giving regular coaching, feedback and guidance. Ensures an engaged and skilled workforce through active listening and communication.

Knowledge, Experience, and Skills
1. Requires a Bachelors Degree in microbiology, chemistry or other scientific field.
2. Requires a minimum ten (10) years progressively responsible quality experience in an FDA regulated GMP environment (such as medical device).
3. Requires a minimum of eight (8) years progressively responsible experience in GLP lab work, performing varied testing and troubleshooting activities in high volume environment.
4. A minimum of five (5) years experience direct supervisory experience. Must demonstrate the ability to lead others by building relationships, provide coaching and feedback to employees, and delegate assignments as needed to ensure efficient work production.
5. Proven excellent verbal and written communication skills are a must as this position interacts at all levels of the organization.
6. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
7. Must have a advanced knowledge of antibiotic / microorganism interactions and GMP compliance.
8. Must be able to demonstrate flexibility in responding to unexpected demands.

The estimated salary range for this role based in California is between $165,000 - 200,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieuxs bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidates experience and will be presented in writing at the time of the offer.
In addition, bioMrieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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