Compliance Manager, 503B

Houston, TX, United States

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

At Empower, the role of Compliance Manager within our 503B Outsourcing Facility is pivotal. Positioned under the direct guidance of the VP of Compliance, this individual is entrusted with the crucial task of ensuring that Empower's operations are in full alignment with the regulatory frameworks set forth by the Drug Enforcement Administration (DEA), the Food and Drug Administration (FDA), and other pertinent regulatory authorities. This role is not just about adherence to standards; it's about leading with foresight, crafting and executing comprehensive compliance strategies that safeguard our commitment to quality and regulatory conformance in every facet of our 503B operations.

Staying ahead of the regulatory curve is paramount. This role demands a proactive approach to understanding and integrating new and evolving federal and state regulations into our practices, ensuring Empower remains a beacon of compliance excellence in the 503B landscape. Acting as a liaison with regulatory bodies, this manager will spearhead communications, manage inspections with precision, and ensure that all reporting is timely and accurate .

This role calls for a visionary leader with a proven track record in compliance program development, a keen analytical mind capable of navigating complex regulatory challenges, and an unwavering commitment to upholding the highest standards of quality and integrity. In essence, the Compliance Manager is a guardian of Empower's ethos, a strategic thinker, and an advocate for best practices in compliance, driving our mission forward and ensuring that we continue to empower lives through innovative and accessible healthcare solutions.

Duties and Responsibilities

Develop s and implement s comprehensive compliance programs for 503B outsourcing facility operations

Conduct s regular assessments and audits to evaluate compliance with applicable regulations, including state, federal, cGMP and other relevant standards and identify areas for improvement

Collaborate s with internal stakeholders to integrate compliance considerations into strategic planning and decision-making processes

Stay s abreast of changes in federal and state laws, regulations and guidance affecting 503 B outsourcing facility operations

Interface s with regulatory agencies, respond s to inquiries, manage s inspections, and ensure s timely and appropriate reporting

Oversee s the development and delivery of compliance training programs for employees, ensuring a thorough understanding of regulatory requirements

Ensure s proper documentation of manufacturing processes and maintain s accurate records to demonstrate compliance

Drive s the implementation of corrective and preventive actions in response to compliance-related issues or identified areas for improvement

Develop s and maintain s effective relationships with internal stakeholders, external partners, and regulatory bodies

Collaborate s with Quality Assurance and other departments to enhance the overall quality management system

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 leadership to evaluate department headcount needs, conducts interviews and selects qualified candidates

Perform s other 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 accommodation 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 stationary for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices.T he 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. Vision abilities required by this job include close vision.

Knowledge and Skills

Strong knowledge of compounding regulations, DEA requirements , and cGMP

Excellent leadership and team management skills

Proven track record of developing and implementing successful compliance programs

Ability to analyze complex regulatory issues and provide strategic guidance

Proficient in Microsoft Office (Excel, PowerPoint , etc. )

Ability to work independently to manage work tasks effectively

Must be detail-oriented and possess a high level of accuracy

Excellent verbal and written communication skills

Ability to work in a fast-paced and changing environment while adapting to changing responsibilities and coordinating multiple job tasks

Ability to prioritize work and meet deadlines

Must be a self-starter and results driven

Sensitivity to confidential documents and information

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

Experience and Qualifications

Bachelor’s or advanced degree in related field

5 + years of experience in a leadership position

Experience with regulatory affairs, inspections, audits, and interactions with regulatory agencies

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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