Validation Manager
The Validation Manager will be a high-impact leader, focused on developing and owning the validation for the Leiter’s business. This role will be part of a high performing team within the quality unit of Leiters. This position will be responsible for developing validation strategies for new equipment, maintaining a state of control over the manufacturing processes, and fostering a quality forward culture across the supporting departments. This leader will partner closely with technical services, facilities and engineering, research and development, and manufacturing, among other groups. This role will leverage deep understanding of risk-based decision making to establish a robust and quality driven validation program.
Why Join Leiters Health?
At Leiters Health, we’re more than just a pharmaceutical company - we’re guided by purpose and our commitment to excellence. With a strong mission to advance patient care and a culture that values integrity, collaboration, and growth, we provide a workplace where your skills make a meaningful impact on healthcare. Whether you’re an experienced professional or just starting your career, we offer exciting opportunities, along with competitive benefits and a supportive team environment.
- Commitment to Quality: Be part of a team that upholds the highest regulatory standards in pharmaceutical compounding, ensuring patients receive the highest quality medications.
- Comprehensive Training and Development: We invest in our employees with ongoing training, mentorship, and career development opportunities to help you grow and thrive.
- Collaborative and Supportive Culture: Join a team of passionate individuals who are dedicated to mutual success. We foster an inclusive and supportive environment where everyone’s contribution matters.
- Opportunities for Growth: As a fast-growing company, we offer exciting career paths, internal promotions, and the chance to advance your skills in a dynamic industry.
- Make a Real Impact: Your work directly contributes to patient care and healthcare-helping hospitals, surgery centers, and clinics deliver life-saving medicines. At Leiters Health, what you do matters!
What We’re Looking For:
Leiters Health is driven by detail-oriented, proactive individuals who thrive in a dynamic, team-based environment. Engaging with excellence in care that matters, we advance patient care by reliably delivering high-quality compounded medications to our healthcare partners. If you are passionate about making a difference and enjoy working in an innovative, growth-driven company, this is the place for you.
Essential Functions:
This description is intended to be illustrative of the major duties performed by the employee assigned to this position.
- Develop strategic direction for the company’s validation program to maintain compliance of equipment and processes in alignment regulatory requirements.
- Strategically creates and leads projects/matters. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group, including the Executive Leadership Team as appropriate.
- Utilizes Project Management skills to plan, lead, and coordinate efforts with a cross-functional team.
- Completes tasks in a timely fashion and communicates task status to Executive Leadership and/or project team.
- Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, CQV protocols and reports, and CAPAs.
- Coordination of Validation activities with stakeholders.
- Performs and documents Validation Gap Assessments and Risk Assessments for highly complex systems, including addressing gaps and mitigating risks.
- Training and mentoring of other technical support staff (Validation Engineers, Process Engineers/Scientists, Research & Development Scientists, Project Engineers, Quality Assurance, Quality Control, etc.) on industry guidelines, expectations, and best practices for validation topics.
- Creates Validation templates for protocols and reports.
- Creates or revises Validation Standard Operating Procedures and Job Aids.
- Supports and reviews Engineering, Manufacturing, Technical Service and R&D Documentation.
- Supports project work in a management capacity on complex technical and business matters.
- Acts as a Subject Matter Expert for some or all of the following topics:
- Commissioning, Qualification, and Validation of direct impact cGMP manufacturing and supporting equipment.
- Stage I-III Process Validation: Process Design, Process Qualification, and Continued Process Verification
- Aseptic Practices (Smoke Studies, Media Fills / Process Simulations, Sterilization, Filtration of air or product, Microbiology including Endotoxin, Environmental Monitoring, and Bioburden)
- Aseptic Process Simulation (Media Fill Validation)
- Cleaning Verification and Validation (Cleaning Processes, Aseptic Cleanliness, Product Changeover)
- Maintain validation budgets.
- Other duties as assigned.
Supervisory Responsibilities:
- Directly hire and lead a team of engineers and/or, scientists and technicians.
- Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
- Conduct regular 1:1’s to address performance, feedback and relationship building.
- Identify training and development needs within the team and facilitate as able.
Experience and Necessary Competencies:
- Bachelors or Master’s degree in Chemical Engineering, Chemistry, Industrial Engineering or related field.
- 7+ years of relevant experience, including 2+ years in a leadership role.
- Experience in a highly regulated FDA environment (preferred pharmaceutical, will consider biotechnology or related fields) including a significant exposure to regulatory requirements.
- Experienced people leader able to communicate verbally and in writing to influence effectively at all levels of the organization. Able to leverage strong storytelling to drive buy-in amongst stakeholders.
- Bias towards action and strong sense of urgency. Passionate about driving results.
- Experience in project management.
- Superior knowledge of regulatory and guidance documentation, including USP, ISPE, and FDA Guidance for Industry publications.
- Demonstrate superior knowledge of operational excellence concepts and tools, such as value stream mapping, tiered daily management, Gemba, standard work, cell and line layout, 3P, Kanban, OEE, waste prevention and cycle time reduction.
- Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through.
- Willingness to support tasks outside normal job description, as needed. Can-do attitude!
- Ability to create technical and professional documents.
- Strong attention to detail and accuracy.
- Ability to multi-task, with strong organization and time-management.
- Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis.
- Proficient written, verbal and oral English communication skills are required.
- Advanced skills with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Physical Requirements:
- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
- Ability to maintain a gowning qualification, if applicable.
Why You’ll Love Working at Leiters:
At Leiters Health, we are committed to creating an environment where our employees can thrive. From health benefits to career growth opportunities, we are here to support your success.
Benefits:
- 100% Employer-Paid Medical Plan Options
- Optional FSA & HSA plans
- Dental & Vision Insurance Options
- Employer-Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching, with 100% vesting on Day 1!
- Generous Paid Time Off (PTO), including vacation, sick leave, paid leave, and holidays
- $1,000 Referral Bonus Program with no limit
- Annual Bonus Program Eligibility
Career Growth Opportunities:
- $5,250 Annual Tuition Reimbursement after 6 months of employment
- Internal Career Center for growth opportunities
- LinkedIn Learning to enhance your knowledge on various topics
- 1-on-1 Coaching from Leadership
- Luncheon Learning provided on various topics from Finance, IT, and more
At Leiters Health, we are dedicated to advancing patient care by reliably delivering high-quality compounded medications to our healthcare partners. If you're ready to take the next step in your career join us and be part of something bigger- where your work truly matters. We are growing rapidly, and we want you to be part of our exciting journey.
Timeline: We will be accepting applications on an ongoing basis until position is filled.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
