Responsible for managing the QC laboratory in accordance with GMP, GLP, customer, and company internal requirements. Lead, organize, and maintain all department and laboratory processes, procedures, and administrative duties.
Act as liaison with external parties on matters relating to QC testing status, approvals, rejections, documentation status, and any other QC matters to support all internal departments and customers.
Develop and implement systems designed to support analytical methods.
Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase and commission of analytical and microbiology instrumentation. Ensure there are efficient instruments for the workload of samples.
Assure adequate communication of priorities exists between the lab and other departments and within the lab.
Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
Assure that all raw materials, bulks, and finished goods are tested in accordance with all regulatory, Company, and customer requirements, as applicable.
Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification activities.
Manages process optimization program that includes continual improvement programs for analyses, human capital development, and management systems.
Overall responsible for the environmental monitoring program, including ensuring weekly monitoring and reporting and generating impact risk assessments and quarterly/annual reports.
Responsible for stability programs and ensuring execution within required timelines. Continuous management, development, and improvement of the stability program.
Responsible for managing method validations/ verifications.
Take lead responsibility with contract laboratories supporting outsourced testing and method development activities.
Investigate deviations and fill related documents as required, utilizing problem-solving tools as needed. A good command of product specifications, process reference files, code of regulations, and Pharmacopeia requirements.
Responsible for investigating and processing deviations, out-of-specifications, and out-of-trend, events. Identify and report non-compliance/deviations/out-of-specification events.
Experience:
5+ years of QC lab experience in the biotech/pharmaceutical industry in a GMP and GLP environment is required.
Experience setting up analytical methods and method validation processes.
Experience implementing and maintaining departmental metrics.
Prior experience working with external testing laboratories and development and manufacturing partners is highly desirable.
Education:
PhD in Pharmacy/Pharmacology is required.
Skills and Knowledge:
Demonstrated leadership and organization skills.
Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels.
Abilities:
Ability to develop and lead a high-performing team.
Communicate clear work plans, coordinate staff schedules, training and standardize work hours among the staff when possible.
Work with various staff members to evaluate and improve processes, through informal and formal channels.
Ability to work on cross-functional teams and apply influencing skills in a matrix environment.
Able to develop solutions for simple and complex problems, which require a high degree of ingenuity, creativity, and innovation. Challenges are frequently unique and solutions may serve as precedents for future decisions, which affect the entire organization.
Familiarity with the operating of measuring tools like HPLC, GC, etc.
