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.

As the Director, Quality 503B at Empower, you will be a cornerstone of our commitment to excellence in pharmaceutical manufacturing. Your role is vital in maintaining the integrity of our drug preparation processes and ensuring compliance with stringent government regulations and standards for current Good Manufacturing Practices (cGMPs) and the Food and Drug Administration’s (FDA) Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B. By directing and monitoring quality standards, you will safeguard and reinforce our mission to provide innovative, high-quality medications that improve the health and well-being of our customers.

In this leadership position, you will oversee daily operational tasks such as batch record creation, review, materials testing, and release, ensuring that our manufacturing processes are error-free and efficient. You will spearhead investigative teams to reduce quality waste and drive operational excellence. Your expertise will be pivotal in developing and managing the Quality Assurance (QA), Quality Control (QC), On-the-Floor Quality, Visual Inspection and Labeling, and internal analytical lab departments.

Collaboration and continuous improvement are at the heart of this role. You will lead Non-Conformance Incidents (NCIs), Deviations, and corrective and preventative actions (CAPA) Investigations, providing analytical analysis for root cause issues. Your responsibility extends to reviewing and driving departmental policies and procedures to keep Empower at the forefront of the pharmaceutical industry.

If you are a leader with a robust background in quality assurance and regulatory compliance within the pharmaceutical industry with a passion for quality and innovation, we invite you to apply for the Director, Quality 503B position. Joining Empower means becoming part of a team dedicated to producing and expanding access to life-changing, quality, affordable medications.

• Directs, monitors, and ensures quality standards and drug preparation process complies with government regulations and standards for cGMPs and/or FDA’s Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B.
• Responsible for directing the teams responsible for batch record creation, review, materials testing and release.
• Provides quality leadership to reduce errors and defects throughout the manufacturing facility.
• Leads investigative teams to drive down quality waste and assist with operational excellence.
• Develops, directs, and manages the QA, QC, On-the-Floor Quality, Visual Inspection and Labeling, and internal analytical lab.
• Oversees the drafting, review, approval, distribution, and maintenance of the following: (1) aseptic technique qualifications and media fill process, (2) and equipment and process validations, (3) operating procedures and specifications, (4) routine change control requests as designated and leads the change control program, (5)raw materials specification limits.
• Leads NCIs, deviations and CAPA Investigations.
• Assists with the analytical analysis for root cause issues. 
• Enters cleanroom and manufacturing space frequently and upon critical incidents to assist with investigations (must be able to gown qualify).
• Reviews test results and inputssummaries into the monthly and quarterly QA report templates.
• Ensures quality records are maintained (equipment calibration and maintenance, training, deviation, and complaint investigations). 
• Leads with drafting and execution any of the above responsible duties in the case of absence or vacancy.
• Stays informed of industry trends, regulatory changes, and best practices and makes relevant updates to departmental policies and procedures.
• Monitors department performance through key performance indicators and operational metrics to track progress and make data-driven decisions.
• Provides leadership, guidance, and mentorship to quality assurance, fostering a culture of collaboration, accountability, innovation, and continuous improvement.
• Completes and communicates annual performance evaluations and provides coaching and feedback to direct reports, recognizing achievements and addressing areas for improvement as needed. 
• Evaluates department headcount needs and actively participates in interview, selection, and onboarding of new employees.
• Provides leadership during regulatory inspections.
• Performs other QA/Regulatory duties as assigned.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

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 occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.

• Ability to work autonomously within established procedures and practices.
• Working knowledge of pharmaceutical regulations United Stated Pharmacopeia <800>, cGMP.
• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211), and Internal Conference on Harmonization regulations.
• Leadership skills and the ability to facilitate the work activities of others.
• Proficiency with computer software, Microsoft Office preferred.
• Good organizational and time management skills.
• Must be able to enter the cleanroom and manufacturing space as needed for audits and escalations. 

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 other accountable to meet commitment.
• 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.

• Bachelor’s degree in technical or scientific discipline.
• 10 years’ experience in pharmaceutical manufacturing.
• 2-5 years’ experience in a senior leadership position.
• At least 5 years required experience with injectables (mix, wash, depyro, fill-finish).

• Preferred American Society for Quality (ASQ) Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or Society for Quality Assurance Registered Quality Assurance Professional.

• Experience with non-sterile operations and terminal sterilization of finished goods preferred.
• Experience in a 503B Outsourcing Facility preferred.
• Experience in a contract development manufacturing organization
• 21 Code of Federal Regulations (CFR) experience required; European Union Annex 1 preferred.
• Experience with international regulatory agencies highly desirable. Thorough knowledge of pharmaceutical manufacturing/controls and cGMP.

• 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.