The Senior Manager, Quality Management Systems would be responsible for administration and oversight of select electronic quality systems such as Audit Management, Vendor Quality, Deviation and CAPA, etc. Provide support to the Quality Systems Group to ensure the CAPA, Change Control and Deviation processes deliver results efficiently and effectively. Experience in document management including authoring SOPs, electronic quality management system maintenance. Collaborate with the business owners (GMP/ CMC, PV, Clinical, IT, etc.) and provide guidance on Quality processes and to ensure successful execution through tracking, trending and general oversight for compliance. Manages the deployment of an electronic QMS System to support all Quality related activities including, but not limited to, deviations, investigations, product review and release, metrics and product quality complaints. Partners with internal stakeholders to ensure the e-QMS functionally supports cross functional teams and the Company’s processes.
- Lead Project Management activities to develop and implement electronic quality systems
- Conduct Business Analysis, System design, testing, data migration, training and roll-out activities
- System administration of eQMS, including account administration, change control, ability to run complex queries
- Ensure deviations, Investigations, CAPAs and Audit records are closed in a timely manner
- Maintain an active, qualified GxP vendor database
- Provide effective computer validation support as Quality – IT liaison for computer system assessments, systems validation and deployment activities, and change control, driving consistency in approach towards validation protocols and execution
- Define metrics and KPIs and develop a Quality Management dashboard to enable Management Reporting
- Manage the implementation and routine reporting of Quality metrics to monitor performance to support and provide recommendations to senior management for continuous improvement.
- Manage the development, implementation and maintenance of all necessary GxP related manuals, policies, processes/procedures and work instructions.
- Provide oversight to on deviations, investigations, CAPA, change control, complaint as related to manufacturing operations.
- Support a culture of quality across the company.
- Establish and maintain a positive working relationship within the Company and with their external business partners as it relates to area of responsibility.
- Assist in the management of regulatory agency inspections.
- Facilitate compliance reviews of technical documentation for FDA marketing applications.
- Other duties as needed.
- Minimum of Bachelor’s degree in a scientific discipline with over 8 years of quality assurance or system administration experience in Biotech/ Pharma.
- Strong expertise in computer validation/ SDLC activities.
- Possess demonstrated knowledge and experience in the interpretation and application of GCPs and PV standards for domestic and international territories.
- Broad and deep expertise related to understanding the principles and application of quality and regulatory compliance with key focus on 21CFR Part11 requirements and equivalent regulations.
- PMP Certification desired.
- Effective communication skills (verbal and written) to influence cross-functional team members, peers and superiors.
- Ability to work well in both internal and external team environments, have a strong commitment to the accomplishment of tasks, adherence to procedures, and has the initiative to identify opportunities for improvements.
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality with attention to detail and accuracy.
- Strong ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Possess strong conflict management and negotiation skills.
- Excellent verbal and written communication skills.
- Self-motivated, able to work independently and be reliable and responsive.
Job Location: Cambridge, MA
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