The Pharmacist in Charge (PIC) will be responsible for both maintaining licensure & regulatory compliance while leading a Quality unit through a period of tremendous growth and opportunity for our pharmaceutical drug compounding 503B outsourcing facility. The Pharmacist in Charge will also function as the quality officer overseeing all quality assurance (QA) and quality control (QC) related items necessary to achieve business objectives associated with product quality & efficacy, regulatory compliance, and overall customer satisfaction. The position will ensure that all facility staff are currently licensed/certified/registered, and that the facility provides optimal pharmaceutical services. This role will provide oversight of the facility quality management system (QMS) while promoting patient safety in accordance with accepted standards of current good pharmacy & manufacturing practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to the following:

* Provides leadership to a team of Quality Supervisors (QA & QC), Specialists, and Associates including onboarding, managing, coaching & mentoring while fostering a "quality culture" mindset

* Upholds multi-state pharmacist licenses, accreditations, and certifications to ensure business continuity and patient care

* Establishes and maintains a quality management system (QMS) to ensure full compliance with all local, state, and federal regulations and guidelines (including FDA 21 CFR Part 211, cGMP, USP, EPA, DEA, and support for OSHA requirements).

* Acts as a responsible leader during external audits/inspections including 3rd party as well as federal & state agencies (ex: FDA, DEA, State Boards of Pharmacy). Supports generation of responses including identification & implementation of remediation actions. Supports the implementation of a site level inspection readiness program.

* Supports the facility document management program including review and approval of SOPs. Defines SOP priorities to sustain operations, compliance, & process improvements.

* Oversees investigation, non-conformance & deviation activities within the facility while serving as the Corrective Action and Preventative Action (CAPA) owner to address operational issues and investigations that directly impact production.

* Adheres to and promotes best practice methods for safe and accurate compounding, dispensing, distribution and control of medications.

* Oversees the receipt, verification, and application of clinical knowledge during fulfillment of orders.

* Ensures the outsourcing facility is providing medication consultation to animal owners.

* Ensures pharmacists have access to veterinary references and training to provide drug information to veterinarians and all other appropriate customers or sales personnel.

* Oversees the facility internal audit program including evaluation/revision of audits, allocation of resources to complete audits & reviews outcomes to ensure actions are implemented to address findings.

* Responsible for the overall execution of the site stability program for the portfolio of Sterile & Non- Sterile products compounded

* Ensures execution of the facility environmental and personnel monitoring program including tracking & trending of data to sustain control of ISO classified production areas

* Reviews and approves product, process and equipment change controls including commissioning/de-commissioning of labs & facilities (ex: SOPs, validation master plans, IQ/OQ/PQ).

* Responsible for adherence to facility training requirements for employees; defines cross training plan & collaborates with facility trainer to establish redundancies while supporting employee growth & development.

* Partners with supply chain team to drive a robust supplier quality management program including supplier qualification, performance oversight & implementation of supplier agreements where needed

* Defines facility quality metrics & periodically reports out as required to internal leadership on progress/mitigation actions, including periodic Management Review.

SUPERVISORY RESPONSIBILITIES

* Role will lead a team of Quality Assurance representatives (Supervisors, Specialists, Associates)

* Dotted line support, oversight, and guidance to the facility staff pharmacists

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE

* Doctor of Pharmacy or BS Degree in Pharmacy Required with a minimum of 5 years of experience within a cGMP manufacturing or a 503B outsourcing facility.

* 2-5 years of supervisory experience is required

* Experience in Quality Systems/Assurance in pharmaceutical, medical device, or comparable industry

* Completion of internal and/or external compounding (Sterile & Non-Sterile) training

* Prior experience in aseptic manufacturing environment is a plus.

* Experience with six sigma methodologies preferred.

* Expert knowledge of FDA 21 CFR 210 and 211, cGMPs, and guidance for industry

CERTIFICATES, LICENSES, REGISTRATIONSCERTIFICATES, LICENSES, REGISTRATIONS

* Must be a Licensed Pharmacist with Current State licensure, in good standing with the resident state of the Pharmacy

* Licensure (or ability to obtain licensure) in non-resident states requiring PIC to hold licensure.

* Certified Quality Auditor (CQA), Manager of Quality (CQM) or Certified Pharmaceutical GMP Professional (CPGP) a plus

COMPETENCIES (SKILLS AND ABILITIES)

* Strong leadership skills and strategic problem-solving ability

* Ethical conduct and alignment with Covetrus Core Values

* Excellent communications and presentation skills; creates and delivers executive summaries, develops reports and presentations as needed to influence business decisions

* Strong collaboration, relationship management, and interpersonal skills

* Proficient in Microsoft Office suite (Excel, Word, PowerPoint, Outlook) and general computer skills

* Understanding of equipment calibration, maintenance & qualification (e.g., IQ/OQ/PQ)

* Familiarity with analytical laboratory testing & operations

* Historical execution and review of internal & external audits

* Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously.

* Independently make difficult quality & compliance decisions

* Advanced knowledge of CAPA management, change control, document management & quality systems required.

* Experience interacting with FDA or other regulatory agencies.

* Knowledge with manufacturing quality assurance (manufacturing, packaging, facilities, critical systems, validation, SPC, etc.)

* Ability to demonstrate high ethical standards, work under pressure, meet deadlines and exercise sound business judgment.

PHYSICIAL DEMANDS/WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* Some business travel required (less than 10% of time) to internal facilities and some suppliers as needed

We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:

* 401k savings & company match

* Paid time off

* Paid holidays

* Maternity leave

* Parental leave

* Military leave

* Other leaves of absence

* Health, dental, and vision benefits

* Health savings accounts

* Flexible spending accounts

* Life & disability benefits

* Identity theft protection

* Pet insurance

* Sales Positions are eligible for a Variable Incentive

* Certain positions may include eligibility for a short term incentive plan

Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.