The Manager – Quality Control manages the activities and associates of a quality control group in efforts that relate to the release, stability, drug product characterization, provable acceptable range (PAR) studies, validation studies and other regulatory reportable testing activities. This individual is responsible for the development, implementation and maintenance of quality control systems. The Manager – Quality Control oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. This individual 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.
_*_ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Responsible for GMP compliance as related to the laboratories, equipment and staff.
- Trains others to independently execute QC test methods and practice all GMP related procedures.
- 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 and the application of related QC systems
- Leads investigations relating to the QC laboratory as well as the applications of any corrective and preventative actions.
- Maintains equipment related data for trending, continuous improvement and application of effective preventative maintenance procedures.
- Ensures effective and efficient operations of the laboratory in terms of workflows, people flows, laboratory equipment, and staff training;
- Maintains 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.
- Responsible for development and execution of tracking procedures for consumable usage, equipment usage/repair.
- Inputs 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.
- Responsible for training and mentoring associates in the Analytical Development & Quality Control Department.
- 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.
SUPERVISORY RESPONSIBILITIES:
- This individual supervises a team of Quality Control Analysts.
QUALIFICATIONS:
- 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.
COMPUTER SKILLS:
- 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.
PHYSICAL DEMANDS:
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
WORK ENVIRONMENT:
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.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above 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.