The Quality Control Manager is responsible for developing and maintaining Quality QC systems for the Analytical department. Achieves organizational objectives through the coordinated achievements of subordinate staff. Establishes departmental goals and objectives and functions with autonomy. Manages the accountability and stewardship of human, financial, and often physical resources in compliance with departmental and organizational goals and objectives. Ensures subordinate supervisors and professionals adhere to defined internal controls. Manages systems and procedures to protect departmental assets. Demonstrated experience in leadership and a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.
Job Responsibilities
1. Achieves organizational objectives through the coordinated achievements of subordinate staff. Establishes departmental goals and objectives and functions with autonomy. Manages the accountability and stewardship of human, financial, and often physical resources in compliance with departmental and organizational goals and objectives.
2. • Ensures subordinate supervisors and professionals adhere to defined internal controls. Manages systems and procedures to protect departmental assets. Responsible for developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.
3. • Responsible for optimization and operation of the quality control laboratory in a biopharmaceutical manufacturing setting, including all related infrastructure, documentation, equipment validation and analyst training. Develops, implements, and maintains quality control systems in accordance with cGMP requirements. Manages all aspects of Quality Control, in support of and in full compliance with established cGMP and company requirements.
4. • Develop staff to improve individual and departmental performance. Department oversight of manufacturing support testing for multiple projects and related stability studies.
5. • Oversight of assay verification, qualification, validation, and tech transfer activities. Verification of maintenance, calibration, and qualification of laboratory equipment. Assist in troubleshooting equipment malfunctions, assay system suitability failures, assay deviations, CAPAs, and out of specifications investigations. Coordinate instrument preventive maintenance and validation activities.
6. • Author and review Quality Control Standard Operating Procedures (SOPs), Assay Qualification Reports, and Stability Protocols
Qualifications:
- Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment.
- In -depth experience related to method development, optimization, validation, and tech transfers.
- Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data.
- Ability to provide support for regulatory and client audits, as well as interact with clients.
- A profound understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products which could include HPLC (MWD, DAD, ELSD, RID detection), UV/Vis Spectroscopy, qPCR, Capillary Electrophoresis, MS, Genetic Analyzer, Place Readers, Gel Imagers, etc.
- Familiarity with analytical testing procedures: AGE, qPCR/dPCR, HPLC (IEX, RP, SEC), Sequencing, Plate Based Assays (BCA, Kanamycin).
- Strong knowledge of pharmacopeia (USP/EP) and regulatory requirements for the industry (ICH, GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs).
- Sets stretch goals and links them to strategic outcomes and business deliverables.
- Strong leadership and motivational capabilities.
- Exercises sound judgment within defined procedures and policies to determine appropriate action.
- Strong scientific, analytical, and problem -solving skills as well as sound judgment, to identify problems and leads efforts to resolve them.
- Ability to be self -motivated, proactive, accountable, and flexible.
- Ability to work well under pressure, handle multiple tasks/projects and meet deadlines.
- High attention to detail, highly organized, and excellent documentation skills.
- Strong communication skills, both written and verbal in the English language, and outstanding interpersonal skills are essential job requirements.
- Accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
- Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
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