Manages the quality control group related to the release, stability, drug product characterization, provable acceptable range studies, validation studies and other regulatory reportable testing activities. Responsible for the development, implementation and maintenance of quality control systems. Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Makes recommendations for corrective action necessary to ensure conformity with quality specifications and ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations. Maintains a database of QC data, as applicable, to observed trends, perform statistical analyses and/or define appropriate specifications and alert limits.
- Understands regulatory requirements and their application as suitably scoped to either support early phase or late phase/commercial release and stability efforts.
- Develops strategies to ensure effective achievement of objectives by delegating responsibilities and organizing work flows while monitoring and evaluating the completion of tasks and projects.
- Collaborates with other senior level personnel to ensure consistent application of company policies and practices as well as promoting new policies and programs tactfully and authentically.
- Provides day to day management of a quality control group.
- Trains others to independently execute QC test methods and practice all GMP related procedures.
- Leads investigations relating to the QC laboratory as well as the applications of any corrective and preventative actions.
- Responsible for contributing to the GMP compliance as related to the laboratories, equipment and staff.
- Maintains equipment related data for trending, continuous improvement and application of effective preventative maintenance procedures.
- Contributes to the effective and efficient operations of the laboratory in terms of workflows, people flows, laboratory equipment, and staff training;
- Contributes to the maintenance of laboratory supplies and inventory.
- May serve as point-of-contact for instrument repairs, calibrations, qualifications, validations and maintenance; and provides technical input to purchasing new equipment.
- May organize and participate in vendor negotiations, product and software evaluations, tutorials and facility modifications.
- Contributes to Department input of budgetary requirements and monitors expenditures.
- Works closely with Analytical Development to ensure new and existing analytical methodologies are appropriately written and/or developed for use in the QC laboratory.
- May participate in contract laboratory audits on an as needed basis to ensure compliance to GMP principles and/or established Quality Agreements as well as manage associated testing activities
- Ensures effective performance management process is in place and specific development plans implemented for each team member.
- Assists with talent recruitment and leads a highly motivated, efficient and effective team.
Education and/or Experience:
- Bachelor’s degree in Chemistry, Biology or related scientific field required.
- Minimum of seven years of experience working in a cGMP regulated environment executing or overseeing Quality Control testing and related activities required.
- Prior supervisory and/or managerial experience preferred.
- This individual supervises a team of Quality Control Analysts.
- Experience in MDI/DPI analytical test methods preferred (i.e. Andersen Cascade Impactor and Emitted Dose Techniques) preferred.
- Previous participation in regulatory audits preferred.
- Thorough knowledge of HPLC, GC, FTIR and various other analytical techniques required.
- Experience with statistical data analysis, DOE, HPLC software systems, trending analysis preferred.
- Experience with the full life-cycle of developing and validating analytical methodologies
- A strong foundation in the principles of cGMP.
- Ability to apply applicable regulations (FDA, EU, Japan, USP, ICH, etc.) in a phase appropriate manner required.
- Must be proficient in MS Office Suite.
- Prior experience with Empower or similar, JMP or similar, experience with an ELN required.
Certificates, Licenses, Registrations: none required
Other Skills and Abilities:
- Excellent oral and written communication and presentation skills
- Excellent organizational skills and attention to detail are essential.
- Ability to manager both day-today operations as well as project work.
- Ability to prioritize and multi-task successfully in a fast paced environment.
- Demonstrates appropriate safety consciousness.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Ability to lift up to 20 lbs.
- Ability to stand for long periods of time
- This position requires minimal travel; average travel for this position less than 10% with some variation based upon the demands of the business imperatives
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Ability to work safely and conscientiously in a laboratory environment; wear appropriate personal protective equipment; communicate with others in the laboratory to mutually ensure continued safe laboratory practices.