Quality Control Manager

medmix•Flowery Branch, GA

About The Position

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2’600 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss As Quality Control Manager, you will be responsible for managing incoming, in-process and final inspections for the manufactured product(s) for the Quality Control laboratory. The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific and technical expertise for QC and transfer activities These activities include the timely qualification of in-process and release testing of drug delivery systems, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectly Review and approval of customer manufacturing batch record Responsibilities include hiring, training, goal setting, and performance evaluation The manager collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditions Additionally, the manager serves as the primary technical liaison with clients and Regulatory Bodies Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing Build a trained, competent team of QC analysts to support GMP testing Coordinate any required daily Quality Control activities Ensure compliance, accuracy, and timeliness of testing processes Lead the introduction of new technology, equipment, methodologies, and validations Provide QC leadership and support across the organization Hire and develop employees within the department Assign work, coach staff, and take vital disciplinary actions Serve as primary QC Bioanalytical contact for regulatory inspections and client audits Provide support for method qualification and validation from Assay Development and Analytics and/or clients Provide frequent overall departmental feedback to senior management Ensure adequate staffing is hired and trained

Requirements

5-7 years of experience manufacturing in a highly regulated quality control lab environment.
Bachelor’s degree
Experience with writing Deviations, Lab investigations, and OOS required
experience with Root Cause Analysis required
Experience with regulatory inspections from the FDA, EMA, Notified Body, or other regulatory authorities required
Capable of writing reports, business correspondence, and procedure manuals
Strong organizational skills with the ability to prioritize and lead through complex processes/projects
Ability to read, analyze, and interpret business periodicals, common scientific, professional, and technical journals, financial reports, governmental regulations, and legal documents
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Ability to effectively present information to employees, top management, public groups, and/or boards of directors
Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical, or diagram form
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems
Able to lead abstract and concrete variables in situations where only limited standardization exists
Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed.
Ability to effectively present information publicly.
Ability to work well with subordinates, peers, and superiors in all departments.

Responsibilities

Managing incoming, in-process and final inspections for the manufactured product(s) for the Quality Control laboratory
Provide leadership and scientific and technical expertise for QC and transfer activities
Timely qualification of in-process and release testing of drug delivery systems, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory
Ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectly
Review and approval of customer manufacturing batch record
Responsibilities include hiring, training, goal setting, and performance evaluation
Collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditions
Serves as the primary technical liaison with clients and Regulatory Bodies
Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing
Build a trained, competent team of QC analysts to support GMP testing
Coordinate any required daily Quality Control activities
Ensure compliance, accuracy, and timeliness of testing processes
Lead the introduction of new technology, equipment, methodologies, and validations
Provide QC leadership and support across the organization
Hire and develop employees within the department
Assign work, coach staff, and take vital disciplinary actions
Serve as primary QC Bioanalytical contact for regulatory inspections and client audits
Provide support for method qualification and validation from Assay Development and Analytics and/or clients
Provide frequent overall departmental feedback to senior management
Ensure adequate staffing is hired and trained