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At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

The Director of Quality Control is responsible for oversight of all operational aspects of the Quality Control function, including project management, raw data/protocol/report review, in-process and product release testing, data trending, reference standards, external auditing, deviations, CAPAs, OOSs/OOTs), change control and compliance. The Director of Quality Control will assess talent to assign tasks, functions, and projects to personnel with the appropriate capabilities and experience.

Essential Functions

• Ensure all QC personnel across all QC Departments are properly trained, and the appropriate resources are provided to successfully fill the job requirements

• Ensure quality control process, systems, and daily work activities are conducted in compliance with standard operating procedures (SOPs) and regulations

• Conduct analysis of departmental activity, resources, and throughput data to determine progress toward stated goals and objectives

• Represent Aldevron as the QC SME for analytical methodologies, specifications and reference standards with clients and regulatory bodies, as required

• Identify, evaluate, and execute process improvements to increase existing capabilities

• Ensure a strong interaction with multiple groups to facilitate appropriate resource allocation and scheduling of in-process and release testing, outsourced testing, environmental monitoring and internal initiative projects

• Direct, review, and approve laboratory method validation protocols and laboratory equipment qualifications

• Represent QC on MRB to assist with the interpretation of test results and disposition or additional steps to be taken for incoming materials, manufactured products and stability samples

• Provide GMP QC guidance and oversight to support programs including, but not limited to technical transfer, method validation and routine GMP testing (raw material/lot release and stability testing).

• Support QC deviations, investigations, analytical method performance trending, and work with external testing laboratories on investigation actions and root cause analysis

• Ensure thorough investigations are performed leading to the assignment of root causes and the implementation of effective corrective and preventive actions (CAPA) to minimize the possibility of recurrence

• Direct the generation and implementation of performance and training programs for QC personnel

• Hire, train, motivate, lead, develop, and evaluate staff assigned to the department, facilitating, and assisting in their growth within Aldevron

• Establish goals, objectives and measures to drive continuous improvement of the QC operations

• Ensure departmental performance adheres to established performance metrics, and departmental tasks are completed by their established target dates

• Oversee QC activities, including the review and approval of test records/forms, final reports, SOPs, MSR’s and CORs

• Ensure drafting and periodic review of SOPs, records/forms, and protocols for in-house QC testing and overall QC operations

• Facilitate the evaluation of new testing applications and instrumentation, assist in preparing justification for new lab equipment, prepare purchase orders and coordinate authorization and procurement

• Identifies, evaluates and executes on approved process optimization that includes continual improvement programs for analyses, personnel development, equipment and data management systems

• Review and approve project order specifications as related to QC activities and internal communications to obtain additional details as necessary

• Assess vendor change notifications from contract laboratories to determine the impact to Aldevron

• Take lead responsibility with contract laboratories supporting outsourced testing, method development and assay validation activities

• Ensure department cold storage unit alarm response, including on-call duties outside of normal working hours

Qualifications

Experience:

• At least 10 years of like industry experience, required

• Previous experience in managing a Quality Control department in industry with a cGMP environment, required

• Experience implementing and maintaining departmental metrics, required

• Experience drafting protocols, data reports and QC/QA compliance documents, required

Education

• Bachelor of Science or Masters in Cell Biology, Molecular Biology, Biochemistry, Chemistry or a related major, required

#LI-LM1.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.