Manager, Validation 503B

Company : Empower Pharmacy

Position Summary:

This role ensures compliance and quality by leading validation efforts aligned with regulatory standards and best practices. The Manager, Validation, develops a skilled team, oversees the validation lifecycle, and drives continuous improvement, collaborating with internal teams and partners to support seamless tech transfers and strategic initiatives.

Duties and Responsibilities:

• Leads and develops the validation team through training, performance management, and collaboration, providing technical expertise to support activities.
• Oversees the validation lifecycle, ensuring compliance with Food and Drug Administration standards through risk mitigation, protocol execution, and reporting.
• Develops validation strategies aligned with industry standards, driving continuous improvement through best practices and modern technologies.
• Facilitates seamless technology transfer by collaborating with Research and Development, Manufacturing, and partners, integrating validation into the quality system, and communicating key insights to leadership.
• Stays current with validation trends by engaging with industry bodies and partners with leadership on staffing and recruitment needs.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills:

• Expertise in Good Manufacturing Practices, sterilization validation, and regulatory standards, including validation processes, Good Automated Manufacturing Practice, 21 Code of Federal Regulations Part 11, and system validations.

• Strong leadership, problem-solving, and project management skills, with the ability to inspire teams, ensure precision, and proficiency in relevant software tools.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications:

• 8 years of validation experience in pharmaceutical or biotechnology industries, including 3 years in a supervisory or managerial role.

• Bachelor of Science degree in a scientific or engineering discipline.

• Certified Quality Engineer Preferred.
• Demonstrated experience leveraging AI in daily work to drive efficiency, solve problems, and enhance decision-making—adept at integrating AI-powered solutions into all workflows.

Benefits:

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: (url removed)

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