Compliance Manager, - Houston, United States - Empower Pharmacy

Description

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

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

Develop

s

, implement

s

, and

maintain

s

compliance policies and procedures for compounding pharmacy operations
Conduct

s

regular internal audits to assess adherence to regulatory requirements and

identify

areas for improvement
Collaborate

s

with pharmacy staff to integrate compliance considerations into daily operations
Stay

s

updated on changes in compounding pharmacy regulations, including USP

and USP

, and

implement

changes

along with

relevant stakeholders
Review

s

and advise

s

on compliance with pharmacists' exercise of corresponding responsibility when reviewing and filling controlled substance prescriptions
Assist

s

in the development and delivery of compliance training programs for pharmacy personnel
Ensure

s

proper documentation of compounding processes and

maintain

s

accurate

records to

demonstrate

compliance
Assist

s

in responding to regulatory inquiries and inspections, working closely with regulatory agencies as needed
Investigate

s

and resolve

s

compliance-related issues, implementing corrective

actions

as necessary
Monitor

s

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
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.
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, an

d 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

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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