Manager QA Validation
16 hours ago
The Manager QA Validation is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron’s Raheen facility.
A typical day might include, but is not limited to, the following:
- Designing and developing policies for validation and ensuring that they are effectively administered and comply with regulatory requirements.
- Leading all aspects of QA validation including reviewing and approving the following types of documents, relating to area functions: Failure investigations, Change controls and associated Test Plan documentation, SOPs, Validation protocols and summary reports, Validation Master Plans.
- Managing Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks.
- Developing and managing validation budget, contracts, and schedules.
- Presenting and defending validation data to FDA and other regulatory agencies.
- Maintaining validation document and software control system.
- Ensuring validation status is maintained for equipment and software use in commercial and clinical manufacturing.
- Organizing QA validation resources assigned to functional area to meet goals and timings; coordinating and prioritizing activities with area management.
- Playing a proactive role in developing and applying new approaches and processes to validation strategies.
- Working with senior managers and executives to create a broad-based validation program.
- Applying complete functional knowledge and awareness of company goals and objectives.
- Supporting employees' work performance; conducting hiring and discharge interviews.
This role might be for you if:
- You have strong leadership and problem-solving skills, with the ability to empower and lead a team.
- You are dedicated to quality improvement and can handle pressure professionally.
- Strong oral and written communication skills, with a focus on collaboration and stakeholder engagement.
- You have a solid understanding of Data Integrity.
- You have a strong understanding and application of GMP and regulatory requirements.
To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes. You must also have a minimum of 2 years of direct people management experience.
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