Manager, Validation

3 weeks ago

Houston, United States Empower Pharmacy Full time
Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on three core values: People, Quality and Service. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you'll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let's revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

The Manager of Validation plays a crucial role in maintaining the highest standards of quality and compliance at Empower Pharmacy. By leading the validation team, this position ensures that all processes, equipment, and systems meet regulatory and industry standards, aligning with our core values of people, service, quality, and innovation. This role is integral to safeguarding the integrity of our products and enhancing our reputation as a leader in innovative medication solutions.

In this capacity, the Manager of Validation will oversee the entire validation lifecycle, from risk assessments and protocol development to execution and reporting. Collaborating closely with Research and Development (R&D), Manufacturing, Quality Assurance, and other cross-functional teams, this role ensures a seamless and compliant tech transfer process, keeping our operations aligned with standards set by regulatory bodies such as the Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation (ICH). This role also fosters continuous improvement by integrating industry best practices and technological advancements into our validation processes.

By developing and implementing a robust company-wide validation strategy, this role actively contributes to Empower Pharmacy's commitment to quality and innovation. The Manager will engage with industry peers, regulatory bodies, and internal stakeholders to stay at the forefront of validation practices and trends, ensuring that our products meet the highest standards and are ready for market delivery. This position is also responsible for guiding and mentoring team members, fostering a collaborative and growth-oriented environment.

If you are passionate about driving excellence and innovation in a fast-paced, quality-focused environment, we invite you to join us at Empower Pharmacy. Help us fulfill our mission of producing innovative medications that help people live healthier, happier lives while expanding access to quality, affordable medication.

Duties and Responsibilities

  • Manages the validation team, ensuring appropriate training, development, and performance management.
  • Leads proactive risk assessment and mitigation strategies related to validation activities.
  • Implementation and development of activities for compliance with validation principles industry standards and company policy.
  • Oversees the entire validation lifecycle, including risk assessments, protocol development, execution, and validation reporting.
  • Collaborates with R&D, Manufacturing, and external partners to ensure a smooth and compliant tech transfer process. This includes ensuring that validation aspects of transferred processes, formulations, or technologies are appropriately assessed, documented, and integrated into the existing quality system.
  • Manages validation activities ensuring all required regulatory standards, including FDA, EMA, ICH, and other applicable guidelines are met.
  • Writes reports and helps implement changes that are needed for existing systems and procedures.
  • Review and troubleshoot anomalies, deviations whilst also resolving and consulting on complex issues.
  • Develops, implements, and reinforces the company-wide validation strategy that aligns with regulatory requirements and industry best practices.
  • Works closely with Quality Assurance, Manufacturing, Engineering, and other relevant departments to ensure alignment in validation activities.
  • Implements and oversees ongoing improvements in validation processes, leveraging industry best practices and technological advancements.
  • Ensures rigorous documentation standards for all validation activities, facilitating clean regulatory inspections and audits.
  • Fosters a creative and collaborative work environment, encouraging teamwork, professional growth, and knowledge sharing among team members.
  • Monitors and evaluates employee performance. Provides feedback, as necessary.
  • Partners with department director to evaluate department headcount needs and participates in the interviewing process.
  • Engages with industry associations, regulatory bodies, and peers in other organizations to remain at the forefront of validation practices and trends.
  • Performs other duties assigned.
While performing the responsibilities of the job, the employee is required to speak 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 a 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. The vision abilities required by this job include close vision. The employee may occasionally be required to lift and move objects up to 30 lbs.

Knowledge and Skills
  • Strong leadership skills with the ability to inspire and motivate a team.
  • Strong knowledge of good manufacturing practices, FDA, EMA, and other regulatory requirements related to sterile drug manufacturing.
  • Proficiency utilizing validation-related software tools and technologies.
  • Working knowledge of Good Automated Manufacturing Practice and 21 Code of Federal Regulations Part 11 compliance requirements.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations.
  • Computer System Validation experience a plus.
  • Project Management experience a plus.
  • Excellent attention to detail.
  • Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
  • Exceptional organizational and project management skills.
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
  • Bachelor of Science degree in a scientific or engineering discipline and a minimum of 5 years Validation experience in the pharmaceutical or biotechnology industries OR a non-science related Bachelor degree and a minimum 8 years of validation experience.
  • A minimum of 3+ years of previous supervisory/managerial experience.
  • Experience with cleaning and sterilization process validation.
Employee Benefits, Health, and Wellness
  • No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
  • Onsite Health & Wellness - IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
  • Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
  • Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
  • Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
  • Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
  • Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
  • FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
  • 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
  • Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
  • Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
  • Rewards & Recognition Program: Your hard work doesn't go unnoticed - enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
  • Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
  • Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
  • Critical Illness: Protect your finances from the expenses of a serious health issue.
  • Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
  • Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
  • Legal Services: Access professional legal assistance to address concerns confidently.
  • Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
  • Pet Insurance: Care for your furry family members with our pet insurance coverage.
  • Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.

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