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Compliance Manager, 503A
Empower Pharmacy Houston, TX
$114k-149k (estimate)
Full Time | Ancillary Healthcare 1 Month Ago
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Empower Pharmacy is Hiring a Compliance Manager, 503A Near Houston, TX

Position Summary:
In the dynamic landscape of healthcare and pharmaceuticals, the role of a Compliance Manager within our 503A Compounding Pharmacy is both critical and transformative. Operating under the strategic guidance of the VP of Compliance, this individual is the linchpin in our relentless pursuit of excellence in compliance, ensuring our operations are in harmony with the stringent standards set by the Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), United States Pharmacopeia (USP), and State Boards of Pharmacy.
This role is not merely about compliance; it's about leadership in setting the standards for best practices within our compounding operations. The Compliance Manager is charged with the development, deployment, and meticulous management of policies and procedures that not only meet but exceed regulatory requirements. This encompasses a proactive approach to internal audits, a collaborative spirit in working with our dedicated pharmacy teams, and a visionary outlook to integrate compliance seamlessly into the fabric of our daily operations.
With a vigilant eye on the ever-evolving regulatory landscape, this role demands a proactive stance in updating and educating our teams, ensuring Empower remains at the forefront of compliance excellence. The Compliance Manager will also play a pivotal role in navigating the complexities of controlled substance prescriptions, embodying our commitment to responsible and ethical pharmaceutical practices.
This role is about empowerment—empowering our team through comprehensive compliance training, empowering our operations through diligent oversight and continuous improvement, and ultimately, empowering the lives of those we serve through unwavering adherence to the highest standards of quality and safety.
The ideal candidate brings a blend of educational background, rich experience in leadership within a regulatory environment, and a profound understanding of compounding pharmacy operations. This individual is a strategist, a communicator, and an innovator, adept at managing the complexities of compliance while driving our mission of providing innovative, quality healthcare solutions.
In essence, the Compliance Manager is a guardian of our values, a catalyst for change, and a beacon of integrity, steering Empower towards a future where quality healthcare is accessible, reliable, and uncompromisingly aligned with the best in regulatory compliance.
Duties and Responsibilities:
  • Develops, implements, and maintains compliance policies and procedures for compounding pharmacy operations
  • Conducts regular internal audits to assess adherence to regulatory requirements and identify areas for improvement
  • Collaborates with pharmacy staff to integrate compliance considerations into daily operations
  • Stays updated on changes in compounding pharmacy regulations, including USP <795> and USP <797>, and implement changes along with relevant stakeholders
  • Reviews and advises on compliance with pharmacists’ exercise of corresponding responsibility when reviewing and filling controlled substance prescriptions
  • Assists in the development and delivery of compliance training programs for pharmacy personnel
  • Ensures proper documentation of compounding processes and maintains accurate records to demonstrate compliance
  • Assists in responding to regulatory inquiries and inspections, working closely with regulatory agencies as needed
  • Investigates and resolves compliance-related issues, implementing corrective actions as necessary
  • Monitors emerging trends and technologies in compounding pharmacy to enhance compliance measures
  • 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
  • Performs 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. 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. Vision abilities required by this job include close vision.
Knowledge and Skills:
  • Strong knowledge of compounding regulations, USP standards, and DEA requirements
  • 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, and interactions with regulatory agencies
Benefits:

  • 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

Job Summary

JOB TYPE

Full Time

INDUSTRY

Ancillary Healthcare

SALARY

$114k-149k (estimate)

POST DATE

03/20/2024

EXPIRATION DATE

07/17/2024

WEBSITE

empowerpharmacy.com

HEADQUARTERS

JERSEY VILLAGE, TX

SIZE

200 - 500

FOUNDED

2009

CEO

SHAUN NOORIAN

REVENUE

$10M - $50M

INDUSTRY

Ancillary Healthcare

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