Quality Validation Manager - Computer Related Systems (CRS) Merrimack Pharmaceuticals
Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
This position is responsible for managing all aspects of Merrimack?s computer related systems validation program for cGxP systems requiring validation/qualification.
Manage, coordinate, and/or perform the development of validation protocols, the execution of validation studies, data analysis, and compilation of the data and results into final reports. Schedule and lead meetings with information technology, quality assurance, and system end user personnel to gain consensus on protocol content, protocol execution, and resolution to failures to meet protocol acceptance criteria. Lead or coordinate, as applicable, investigations into failures to meet protocol acceptance criteria. Review and approve validation protocols and reports. (40%)
Review proposed changes to validated computer systems and identify the validation requirements necessary to maintain the system?s validation status after execution of the change. (20%)
Author and administer a corporate computer system validation policy and chair the associated computer system validation panel. Develop and standardize appropriate procedures to be used in validating computer systems, manage and control validation documentation in collaboration with QA. Ensure the validation policy is focused towards achievement of 21 CFR Part 11 compliance. (10%)
Develop validation lifecycle master plans and execution plans for computer system validation projects; develop and manage the associated validation project budgets. (10%)
Train internal or contract personnel who will be executing computer system validation protocols on how to execute the protocols. (5%)
Review proposed new computer systems or software applications that require validation and provide Validation?s perspective on these systems. (5%)
Work with other Validation Personnel to assure consistency in computer validation of testing, utility, process, and equipment/instrument control and data acquisition systems. (5%)
Perform qualification audits of IT vendors and resources. (5%)
Identifying current and anticipated requirements for compliant computerized operations and suggesting methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance with the appropriate federal and international regulations.
Developing computer validation policies, procedures and protocols; investigating/troubleshooting validation problems for computer systems, automated equipment, and control systems.
Keeping abreast of evolving federal and international regulatory requirements, government audit policies, the availability of current techniques and literature regarding compliant computer operations, and serving as an information resource.
B.S. with 7-12 years of validation experience or M.S. with 5-10 years of validation experience.
Experience in validating computer systems in the biopharmaceutical or pharmaceutical industries.
Demonstrated experience in successfully managing complex validation projects is required.
Preference given to candidates with previous and successful validation of Laboratory Information Management (LIMS) systems, system control and data acquisition systems, electronic Quality Management Systems (eQMS), Enterprise Resource Planning systems (ERP), and in implementing 21CFR Part 11 requirements.
This position requires excellent leadership, organizational and communication skills, and a thorough knowledge and understanding of FDA and international validation requirements and expectations. The incumbent must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed, and meet project deadlines and budgets.
The incumbent will be involved in a wide range of complex, cross-functional area problems, which require the regular use of ingenuity and creativity, working without appreciable direction, and exercising considerable latitude in determining assignment objectives. She/he may determine the methods and procedures used on new assignments. Completed work is reviewed from a relatively long term perspective for desired results.
Travel to other locations and to vendors for audits will be occasionally required.
While this position may not have direct reports, it is expected to provide guidance or oversight to company personnel and contractors.
This position will have frequent contact with senior management and outside senior professionals and act as the prime validation contact for the project group.
The position will also be the point person for the CRS validation program to inspectors during regulatory inspections/audits.
||One Kendall Square |
Building 700, Second Floor
Cambridge, MA 02139