Join a team with a unique employee culture that doesn't just talk about core values, but exemplifies them in everything we do. They are: do the right thing, quality matters, and question everything. We believe in investing in our people to play to their strengths and have the right people in the right seats. All employees have 15-minute weekly check-ins reviewed by their manager and yearly performance reviews to ensure clarity of job expectations. To learn more about our culture, please visit our Career page on our website.

About the role

We are seeking a Director of Compliance to be the general resource for all pharmacy compliance matters as well as assisting in the creation of all employee training and education. This is a full-time position with a hybrid schedule (in office four days a week) and will report directly to the VP & Chief Pharmacy Officer.

What you'll do

Oversee and maintain the Compliance Program at Valor, including standard operating policy and procedures governance are aligned with state and Federal drug laws as regulated by the State Board of Pharmacy, the Drug Enforcement Administration, and the Food and Drug Administration
Act as Valor’s accreditation in-house expert, manage applications, renewals, trainings, and inspections, and advise SOP changes as needed
Run Valor's compliance training program using learning management systems, including Simplify 797 and quality management system, Propel.
Ensure pharmacists, technicians, and staff are professionally developed and trained in the required frequency to support operations
Coach and ensure proper training of all pharmacist-in-charge (PICs) for their respective states
Conduct research and create compound formulations as needed
Manage all requirements, applications, and maintenance of all current and future accreditations and multi-state licensing, including PCAB, LegitScripts, and NABP. Advise when policies and practices affect these accreditations
Interim management and then oversight of pharmacy lab equipment maintenance documentation, scheduling, certifications, and compliance
Actively prepare documentation needed for pharmacy inspections
Report on compliance issues and review investigation reports to recommend appropriate corrective actions as necessary
Run unexpected internal audits and inspections to ensure compliance and measure the efficiency of new processes and polices.
Ensure continued compliance with all federal, states, and local regulations related to compounding, including USP 795, USP 797, and USP 800, and state boards of pharmacies
Appropriately report compliance issues and advise Compliance-Operations team on pharmacy compliance matters, including but not limited to controlled substance laws, licensing requirements, and other
Ensure all pharmacy and employee licenses, certificates, compliance trainings, and paperwork are up-to-date
Respond to the board of pharmacy, with consultation with appropriate PIC, in regard to any warning notice issued and/or letters of correspondence
Stay abreast of evolving regulatory and industry standards that are relevant, and ensure that appropriate action and communication is provided
Manage the Compliance Collection in the company’s digital knowledge base
Prepare compliance reports and lead the Compliance meetings and engage all PICs on a regular determined frequency for monthly compliance reporting, and/or quarterly reporting
Collaborate and approve as needed materials related to human resources policies and procedures, and sales and marketing collateral, including website content, social media posts, package stuffers, and doctor and patient education videos and written forms
Accept final accountability for all actions, decisions, and results of the pharmacy, including accountability for failed audits and/or violation of applicable laws.
Always maintain HIPAA compliance; Serve as HIPAA Privacy Officer
Other relevant duties as assigned

Skills and Abilities

Deep knowledge of pharmacy regulations: Familiarity with federal and state laws including those governed by the DEA, FDA, and State Boards of Pharmacy
Accreditation and licensing proficiency: Experience managing applications, renewals, and compliance for bodies like URAC, PCAB, NABP, etc.
Understanding of USP Standards: Expert-level understanding of USP 795, 797, and 800
Inspection readiness: Ability to prepare documentation and manage audits/inspections from regulatory and accreditation bodies
Policy & SOP development: Skill in reviewing, and revising SOPs to align with evolving regulatory expectations
Training program development: Ability to design and deliver ongoing training programs for pharmacists and pharmacy staff
Internal audits: Capable of conducting internal audits and self-inspections to proactively identify compliance risks
Team coaching & mentoring: Experienced in guiding and coaching PICs and staff across states
Cross-functional collaboration: Strong communication skills for working with HR, Data, and Operations
HIPAA Privacy Officer: Must have a thorough understanding of HIPAA and privacy protocols
Stakeholder engagement: Skilled in preparing and presenting compliance reports to leadership and staff
Proactive problem solving: Capacity to anticipate issues and propose regulatory-compliant solutions

Qualifications

Should be able to create documents from an adult learning perspective
Minimum 5 years of experience in a compliance, clinical, or regulatory role
At least 2 years in a leadership role, managing compliance, accreditation, or multi-state pharmacy operations
Hands-on experience with state and federal audits, inspections, and licensing
Experience with LMS platforms like Simplify 797, Propel, or equivalent
Previous experience in a compounding pharmacy environment is highly preferred
Comfortable with change management in highly regulated environments
Ability to acquire and present, with guidance, technical information through independent reading, interviews with subject matter experts and specialists, interpretation of workflows, flowcharts, or other appropriate methods
Ability to work with personnel on all levels of an organization
Ability to work under pressure, multi-task, adjust to changing business needs, and meet deadlines
Pre-employment Drug testing is required

Nice to Have

Doctor of Pharmacy (PharmD) from an accredited institution
Licensed Pharmacist in good standing with one or more state boards of pharmacy
Additional licenses in other states is a plus, especially for a multi-state operation
USP 795/797/800 Training Certificates

Why Work at Valor

You want a career in pharmacy or compounding
You are looking for opportunities for growth and promotions
You love learning new skills and are open to feedback to improve your work product
You believe in and can demonstrate our core values
You value having a 15-minute weekly check-in reviewed by your manager
You are comfortable with fast-paced, dynamic, and growing pharmacy business in the heart of Berkeley, CA

Valor’s pay band range for this position is $72 to $75 per hour. This salary range may include multiple levels. Your level is based on our assessment of your interview performance and experience, which you can always ask the hiring manager about to understand in more detail. Salary is just one component of Valor’s total compensation package for employees. Your total rewards package at Valor will include employer contributions for employee premiums of medical, dental, and vision coverage, long-term disability, life and accidental death and dismemberment insurance, 401(k) retirement plan with safe harbor match and profit sharing plan, monthly catered employee celebrations lunch, PTO and Holiday pay policy, and other benefits.

The purpose of this document is to provide a general summary of essential responsibilities for the position and is not meant as an exhaustive list. This document does not reflect all job duties or requirements for every position. Requirements build as one progresses through the job levels, so any job duties required at a lower level may be required at the higher level in addition to the duties listed for that higher level. Duties, assignments, and other responsibilities may differ for similar positions based on business conditions, departmental or geographic location, and/or needs for the particular position. An individual must demonstrate successful performance in their current position before being considered for promotion. In addition, in order to promote into a higher-level position, a business need for the promotion must exist and the candidate must be considered the most qualified person for the new position. Completion of certain milestones such as obtaining an advanced degree or certification, time in current position, or developing skills to perform at the higher-level role do not guarantee a promotion.

Valor Compounding Pharmacy, Inc. is an At-Will and EEO employer. We have a diverse group of hardworking people who thrive in dynamic environments. In 2020, Valor was ranked in Inc. 5000's Fastest Growing Private Companies, awarded by the San Francisco Business Times Leadership Trust, and accredited by the Pharmacy Compounding Accreditation Board (PCAB). We are a multi-state licensed 503A sterile and non-sterile compounding pharmacy. We pride ourselves on our innovation, data driven decision making, and quality in patient care, medications, and experience.

We adhere to the California Consumer Privacy Act (CCPA). For information about our privacy policy, please visit our Privacy Notice.

The pay range for this role is:
72 - 75 USD per hour(Berkeley)

Valor Compounding Pharmacy, Inc. jobs

Director of Compliance