Senior Manager, Quality Assurance

Join our QA leadership team in San Diego as our Senior Manager of Quality Assurance supporting Biotheranostics, a wholly-owned subsidiary of Hologic, Inc., which develops and provides molecular-based diagnostic, prognostic, and predictive tests that support physicians in the individualized treatment of cancer patients.

This role is for you if…

• You have a strong understanding of Quality Management Systems as is applied in a CLIA laboratory environment along with working knowledge of Quality Management Systems as is applied to a medical device manufacturing environment
• You are an experienced leader who thrives on mentoring and leading others.
• You work well as part of a cross-functional team and are highly adaptable to working in a fast-paced, matrix environment.

Key Outcomes

• Participate in efforts to define and execute Laboratory Developed-Testing (LDT) oversight.
• Lead third-party audits and inspections.
• Facilitate efforts of the CLIA laboratory to investigate and resolve quality incidents as appropriate. Ensure QA documentation of such events including incident reports, complaint files, investigations, corrective action and preventive actions (CAPA) meet the standards described in the Quality Management Plan.
• Oversee maintenance of current federal and state clinical laboratory accreditations, licenses, certifications, and permits.
• Create mechanisms for accountability and metrics tracking.
• Provide site training on quality processes.
• Continually assess quality operations in relation to corporate strategies and the company’s corporate compliance program, as well as identify improvements.
• Maintain the QA function and define the overall quality strategy to ensure the achievement of our overall commercial and corporate objectives.
• You will have input to design and will monitor the implementation and maintenance of Biotheranostics' Quality Management system for compliance with CLIA regulations, College of American Pathologists checklists, and applicable state requirements.

Do you have what it takes?

• You have a minimum of 5 years of experience in Quality Assurance/Systems in a CLIA laboratory environment.
• You are a good communicator, a team player, and have meticulous attention to detail. You are able to work independently and can follow procedures to a T.
• You will give routine updates and communications to the Compliance Officer, General Counsel, and other members of the executive team and company-wide, as needed, to ensure transparency and awareness of progress towards meeting corporate business objectives.
• You will serve as a key resource to support quality education and risk mitigation for the organization (e.g., root cause investigations and corrective and preventive actions).
• Strong aptitude for troubleshooting and resolving issues through collaboration and clear communication with executive team members and others.
• You have developed and implemented quality systems.

Additional Qualifications and information

• Familiarity with CLIA regulations (42CFR493) is highly preferred.
• Bachelor's degree required, in life sciences, physical sciences, engineering, or other applicable technical field.
• Knowledge of LDT in a CAP-accredited and CLIA-certified laboratory is highly preferred.
• ASQ certification preferred.
• MS in Business Administration or advanced training in quality systems preferred.

All around the world people are looking for an answer, a test result, or a procedure that will offer them clarity and a path to a healthier life. By working with products that make a difference, your impact can be more significant than ever imagined. Hologic offers a space for employees to own their passion and feel a sense of purpose each and every day.

Apply now!

The annualized base salary range for this role is $131,900 to $219,800 and it is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency And Third Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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