Senior Quality Operations Manager
5 days ago
About This Job:
This role is responsible for the development and maintenance of the Quality Management System (QMS), with a focus on the CAPA Management System. This involves implementing, executing, and administrating QMS programs, policies, processes, procedures, andcontrols in compliance with evolving global regulatory requirements of the Pharmaceutical and Medical Device industries (as applicable).This also involves supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs, and other functions thatoperate under the QMS. Contributes to the development, implementation, and successful execution of the Quality Assurance mission, objectives and strategic plan.
Essential job responsibilities:
Ensures collaboration and builds partnerships with stakeholders to execute quality strategies for driving continuous improvement through the Quality System.
Participation in the development and execution of the Quality Assurance internal system audit schedule, conducting audits, monitoring adherence to company policies and applicable regulatory requirements, and reporting findings to audited departments forissue resolution.
Active participation in the management of the Corrective and Preventive Action Program, tracking completion of required corrective and preventive actions as a result of reported quality issues (e.g., nonconformities, internal audits, and external regulatoryinspection commitments)
Develop and utilize tools to track, trend and report compliance metrics to ensure systems and processes are suitable, effective, and comply with regulatory authority requirements.
Compile and analyze compliance metrics for presentation as part of the Management Review Program.
Monitoring current industry compliance trends, emerging regulations and regulatory intelligence to ensure maintenance of the Quality Management System.
Author, revise and perform maintenance of department controlled documents (e.g., SOPs, WPDs, etc.) as necessary.
Develop and deliver training on compliance and education for Quality Management System processes.
Provide guidance on regulatory requirements and compliance to functional areas, and represent the company with regulatory authorities by facilitating/supporting regulatory inspections and third party audits, as required, in collaboration with appropriatefunctional areas, to ensure successful inspectional outcomes.
Essential Knowledge & Experience:
Excellent Quality Assurance experience in the Pharmaceutical industry
CAPA Management System leadership
Good project management experience in multicultural global setting
Proficiency in Microsoft suite
Strong interpersonal skills and experience in cross cultural environment
Ability to negotiate and build consensus for plans and priorities, able to develop effective relationships with colleagues and stakeholders
Excellent oral and written communications well as presentation skills.
Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to the complex problems and build consensus across the global organization
Ability to generate insights and leverage learnings individuals, teams and functional level.
Strong planning and organizational skills and experience managing multiple priorities simultaneously
Preferred Knowledge & Experience
Advancd degree preferred
Education and Qualifications:
Bachelors degree in related area
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