Senior Manager, Validation
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Validation Senior Manager is an essential part of Quality’s management team. The Validation Senior Manager will assist in management of the daily activities of the Validation Department and will report to the Director of Compliance and Quality Systems. The Validation Senior Manager will be responsible for overseeing the validation activities of the site, review of applicable change controls and maintenance activities, and revision of the essential validation documents including the Validation Master Plan.
The Validation Senior Manager will work with other departments to make sure the risk assessment, IQ, OQ and PQ activities associated with new components, equipment (including laboratory testing equipment), systems, and utilities are performed according to established schedules, user requirements and needs. This position is also responsible for managing the activities of the Validation Department during facility shutdown activities and ensuring the plant is in a ready state to manufacture
Essential Duties and Responsibilities:
Responsible for providing leadership to the employees within the Validation Department. Performs duties of a manager such as developing annual goals and objectives for department, developing, implementing and managing annual operating budget, approving expenditures, monitoring staffing, addressing employment issues, ensuring compliance with regulations and policies, and managing the overall functions of the Validation Department.
Reviews and approves Validation Master Plans related to cleaning, facilities, packaging systems, and computer-related systems for the facility.
Reviews and approves qualification, validation, re-qualification, and re-validation documents for equipment and systems, as well as manufacturing process protocols and final reports.
Provides validation assessments for facility, utility, and equipment changes as well as input related to product technology transfers to the facility.
Coordinates validation activities with section supervisors to ensure timeliness with minimal disruption to production schedules.
Serves as the Validation liaison between the site and customers or regulatory agencies during facility audits/inspections.
Develops and supports departmental strategic goals to assure the highest quality standards and regulatory compliance.
Ensures records, and procedures are in compliance with current Good Manufacturing Practices (cGMP).
Directly supervises six employees in the Validations Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Education and/or Experience:
Bachelor’s Degree in Engineering, Life Sciences or Computer Science with 6+ years of experience in pharmaceutical validation (aseptic/sterile product facility), or equivalent experience. BS degree in a scientific discipline with at least 6 years of experience, or MS degree with at least 4 years of related experience.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Proficient in the use of MS Word, Excel, Outlook and Access
Other Skills and Abilities:
Excellent Communication skills, both verbal and written
Ability to organize time in order to successfully manage multiple projects and priorities
Ability to read, understand, interpret and implement technical writing and instructions.
Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals
Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.
Must pass background check and drug screen
Shift: Standard 8
Packaging And Labeling