Pharmaceutical Manager, AuditsHybrid
At Medvantx, we deliver care that goes beyond the pharmacy. We offer our customers a better way to support their patients through innovative patient-centric pharmacy practices, nationwide dispense, and fulfillment services. For over two decades, we've been committed to enabling access to fast and affordable care. At Medvantx Pharmacy Services, you'll play a crucial role in our efforts to do just that.
THIS ROLE IS HYBRID. THE CANDIDATE MUST RESIDE WITHIN 4-5 HOURS OF SIOUX FALLS, SD OR LOUISVILLE, KY.
Medvantx is searching for a creative, resourceful, integrative thinker for an important role that is responsible for leading and overseeing Customer, Vendor, and Internal Audits. In this position, the individual will be an integral contributor to Medvantx continuous improvement efforts by championing organizational process and system excellence.
- Develop a risk-based and fit-for-purpose audit schedule that reflects an appropriate level of review across all areas and obtain endorsement from key stakeholders as well as Quality management.
- Monitor the progress and maintain updates to the audit schedule.
- Lead and conduct Customer, Vendor, and Internal Audits, and support Regulatory audits as needed.
- Support the hosting and management of audits, both onsite and in a virtual setting.
- Manage all aspects of the audit lifecycle including audit requests, scheduling, planning, drafting, and issuing audit agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing audit observations, follow up on audit response, and closure of audits.
- Ensure audit reports are timely and robust, listing the applicable regulations potentially at issue, providing specific examples where gaps could exist, noting positive examples/best practices observed, and providing suggestions for future improvements.
- Drive Risk Mitigation and Continuous Improvement initiatives by partnering with functional stakeholders during the audit observation response and ensuing CAPA processes.
- Develop or enhance department policies and procedures while ensuring ongoing and continuous compliance with applicable regulations.
- Lead or assist in investigations to determine root cause analyses for CAPAs
- Lead or assist in managing serious breach and/or CAPAs
- Track all CAPAs along with status
- Contributes to process improvements
- Establish, deploy, and manage the development of an effective internal audit / vendor quality auditing / assessment program
- Mentor junior staff in the accomplishment of their assigned duties
- Experience conducting internal or vendor audits
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
- Ability to adapt quickly to shifting needs and/or priorities.
- Able to interface well with all levels of personnel.
- Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
- Strategic thinker, open-minded and flexible to adopting new ideas.
- Motivated, committed and self-managed.
- Exceptional attention to detail.
- Experienced leader or mentoring experience
- Excellent written and oral skills
- Bachelor’s degree required.
- 6+ years of experience in the pharmaceutical or biopharmaceutical industry.
- 5+ years of experience in a Quality Compliance related role.
- 3+ years conducting customer, internal, or vendor audits
- Requires travel up to 30%
- Quality Assurance Qualification/Certification
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to sit, climb, balance, stoop, kneel, crouch, or crawl. The employee must frequently lift and move up to 20 pounds and occasionally lift and move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Ability to sit at a computer terminal for an extended period.
Will have managerial responsibility
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, obligations, and activities may change at any time with or without notice.
Medvantx Pharmacy Services helps pharmaceutical brands do more than just survive in an ever-changing marketplace – we help them thrive in it. Medvantx provides powerful and personalized support to pharmaceutical manufacturers, health care providers, and their patients. We service the specialty needs of pharmaceutical manufacturers by offering patient assistance programs and providing efficient intake solutions, nationwide dispense and fulfillment services, quality aftercare through counseling and customer service, safe and secure data handling, dependable inventory management and logistics, and insightful reporting and accounting. Serving more than 50 pharmaceutical manufacturers and managing more than $7.5 billion of prescriptions annually, Medvantx has been redefining pharmacy for over 20 years.
Medvantx is proud to have earned Verified Internet Pharmacy Practice Sites® (VIPPS®) accreditation through the National Association of Boards of Pharmacy® (NABP®). Only 5% of online pharmacies meet the nationally endorsed standards of quality, safety, and security set by the NABP®.
Medvantx is an equal opportunity employer. We do not discriminate based on race, religion, color, national origin, gender (including pregnancy, childbirth, or related conditions), sexual orientation, gender identity, gender expression, age, veteran or disability status, or other protected characteristics.
AmeriPharm, Inc. and Vytal, LLC are wholly owned subsidiaries of Medvantx, Inc. a Delaware Corporation.