Position Summary:
The Manager, Quality Management Systems & Validations is responsible for overseeing and managing Ocular's QMS and Quality Assurance Validations activities to ensure compliance with regulatory requirements and Ocular standards. Key QMS responsibilities include overseeing the management of Quality Events processes (Deviations, Corrective/Preventive Actions (CAPAs), and Change Controls) as well as the continuous improvement of Ocular's QMS.
Key QA Validations responsibilities include leading and overseeing the validation of GxP systems and processes, managing review and approval of validation activities, ensuring the validated status of the systems, cross-functional collaboration on projects risk assessments and deviations, and continuously improving the QA Validation Program.
This is a critical position within the Quality organization and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the Senior Director, Quality Assurance.
Principal Duties and Responsibilities:Validations:- Maintaining the validated state of all GxP systems to ensure they operate in a state of compliance with internal procedures, regulatory requirements, and industry best practices.
- Leading, directing, and advising on validation activities, which include the review and approval of validation protocols and documentation.
- Working cross-functionally with other departments on a variety of projects, including risk assessments, and Quality Events associated with validations.
- Leading continuous improvement initiatives for the Validation Program to enhance effectiveness and efficiency.
- Ensuring the integrity of data generated by GxP systems.
- Maintaining Ocular's QA Validation Program in a state of compliance and inspection readiness.
- Participating as the SME during regulatory/internal inspections for QA Validations topics.
QMS:- Leading, planning, and managing Ocular's QMS, acting as the technical expert of Quality Events topics.
- Leading/overseeing routine QA activities associated with the lifecycle of the Quality Events, including initiation, investigation, and closure.
- Developing and implementing policies, schedules, and guidelines for the appropriate management of Ocular's QMS.
- Leading the Change Control Review Board forum and providing guidance to the owners and collaborators of Change Control records.
- Supporting the transformation of Ocular's QMS aimed to optimize the systems and add efficiency to the processes.
- Establishing communication forums to disseminate information on QMS policies and other topics to all Ocular staff.
- Participating in cross-functional teams to resolve Quality Events potentially impacting Ocular's operations.
- Developing, trending, and reporting relevant Quality Metrics associated with the Deviations, CAPAs, and Change Controls.
- Directing and advising on Facility related work orders
- Maintaining Ocular's QMS in a state of compliance and inspection readiness.
- Participating as the SME during regulatory/internal inspections for Quality Events topics.
Requirements:- Bachelor's Degree in Life Sciences or related field.
- 10+ years of experience in the pharmaceutical industry with cross-functional experience.
- Experience leading and working in a GxP setting (commercial and/or clinical).
- Experience in e-QMS and compliance.
- Experience supporting the management of Quality Events and validation activities.
- Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others, associated with QMS and validations.
- Experience with external regulatory inspections (e.g., FDA).
- Excellent organizational skills and attention to
- Strong interpersonal, verbal, and written communication
- Computer literacy, proficiency in MS Word, Excel, PowerPoint,
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Salary Range
$143,000-$152,000 USD
