Salary : $125000 - $145000Senior Manager/Quality Assurance - Biotechnology/Biopharma Our client is a Long Island, NY based biotechnology company developing and commercializing technologies to manufacture and detect DNA and RNA for a variety of applications. They are searching for a Senior Manager of Quality Assurance. They offer highly competitive salaries, excellent benefits, world-renowned leadership, and a collaborative, growth-oriented environment that has driven their amazing success. The Sr. Manager of Quality Assurance is a hands-on individual, experienced in biopharmaceuticals, life sciences, or biotechnology that will lead the management of the company's quality control laboratory operations, building the capabilities to meet ISO13485 and cGMP standards from its current foundation in industrial product quality control businesses. This individual will be responsible for the management of Quality Control for released products, microbiological testing, environmental monitoring, customer product testing, and raw materials testing. Testing will be managed for in-house resources and at outsourced labs. The position includes laboratory strategy, equipment/instrumentation selection and implementation, training and team building, and preparing for and participating in inspections by customers and regulatory agencies. The ideal candidate will be a great team player with a proven track record in biopharma laboratory operations with excellent organizational talent, outstanding communication skills, project management skills and effective management abilities.Responsibilities:
- Lead the Quality team under ISO9001, ISO 13485 and cGMP quality systems. Manage proficiency testing of staff. You would have at least two direct reports.
- Independently perform hands-on testing as needed utilizing high performance liquid and gas chromatography, dissolution testing, gel electrophoresis, capillary electrophoresis, fragment analyzer, endotoxin, FTIR and other quantitative and analytical techniques.
- Develop, validate, and document analytical methods and standard operating procedures according to specific sample or testing requirements. Collaborate with R&D and other groups to ensure efficient, effective method development and transfer into the QC lab.
- Manage outsourced testing resources for analytical assays such as next-generation sequencing, mass spec, UHPLC and others which you may recommend.
- Perform data analysis and interpretation and prepare well-written scientific reports.
- Qualify new instruments (IQ/OQ/PQ), manage ongoing preventive maintenance programs and participate in software validation as necessary.
- Work cross-functionally with manufacturing, R&D, sales to complete GMP implementation and to ensure ongoing compliance to quality and regulatory standards.
- Participate in selection of and working with consultants or other third parties needed to complete the implementation of cGMP/ISO13485 environments and to support ongoing troubleshooting and instrumentation needs.
- Provide support to management and other teams for regulatory agency inspections, customer visits, and customer sales meetings.
- Manage the ordering and upkeep of lab equipment, including purchases (price negotiation and installation), and facilitate interactions with equipment vendors for service calls and routine maintenance
- Maintain appropriate documentation (records and lab notebooks) as required by SOPs.
- Comply with all cGMP and safety requirements, laboratory SOPs, and company policies and procedures.
- Prepare reagents, solutions, and standards as required.
Job Requirements:Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 5+ years of experience executing and leading quality operations in the biopharma / pharmaceutical industry.
- Master's degree in biology, molecular biology, chemistry or other life science. PhD is a plus.
- Expertise in nucleic acid (DNA or RNA) manufacturing and quality method development and analytics for HPLC, UPLC, gas chromatography, and mass spec
- Experience with environmental monitoring and microbiology assays such as endotoxin testing, protein clearance
- Experience with ISO9001, ISO13485 and/or cGMP quality systems
- Comfort in a fast-paced, growth environment, with the demonstrated ability to oversee multiple workstreams and shifting priorities
- Strong collaborator and committed team player, with exceptional organizational, record-keeping and communication skills, both verbal and written
- Knowledge of laboratory safety and associated regulatory guidelines, and experience in handling and managing laboratory chemicals and biological materials, chemical and reagent inventory
- A deep passion for innovative science and a desire to make a clinical impact in the exciting field of genetic medicine
- Ability to maintain professional and productive relationships with internal colleagues and external collaborators
- Willingness to learn, teach, and grow in a fast-paced environment
- Experience with document control systems, databases, Microsoft Office and Google Workspace are preferred.
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Contact Details: Scott Passeser, Sr. VP ...@execsallied.com Executive Alliance Commack, NY 11725