Quality Control Laboratory Manager

Job Description

Essential Duties and Responsibilities:

• 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.