Senior Quality Manager - Pennsylvania, United States - Jubilant Radiopharma

Description

Jubliant DraxImage Radiopharmacies, a nationwide radiopharmaceutical company, is dedicated to nuclear medicine. We use our 25 years of experience in Nuclear Pharmacy to provide our customers with the best service and safest products. The Jubilant Radiopharmacies Network of facilities positions us to serve national GPO's, regional systems, as well as standalone clinics and hospitals. Through our open formulary, we provide choice by giving our customers access to all radiopharmaceuticals available, allowing them to better serve their patients. Jubilant Radiopharmacies provides the strength of national coverage while remaining connected to our local community. We are patient focused and community driven to ensure that we are intimate with our healthcare partners' needs.

We are currently seeking a Sr, Manager, Quality to support our pharmacy operations.

Responsibilities:

The Senior Manager of Quality is tasked with overseeing and ensuring the highest standards of quality and compliance in the production and distribution of radiopharmaceuticals. This role involves the development, implementation, and continuous improvement of quality management systems, processes, and procedures to meet regulatory requirements and industry best practices.

• Create, execute, and uphold a thorough quality management framework that complies with both BOP and FDA standards for Jubilant Radiopharmacies. Guarantee that all processes adhere to governmental regulations as well as the objectives and policies of the organization.
• Lead and manage quality assurance teams across US radiopharmacies.
• Establish, put into practice, and sustain a nuclear pharmacy quality audit program to ensure adherence to relevant FDA and Board of Pharmacy regulations. Oversee the pharmacy audit team and ensure that the Pharmacy Manager implements corrective measures, in collaboration with the JDR Management team.
• Develop, implement, and maintain program for nuclear pharmacy reporting of quality and safety related incidents.
• Develop, maintain, and present quality and safety related metrics to JDR Quality Senior Management, regulatory agencies and/or customers.
• Coordinate incident investigation and response to patient safety incidents to assure appropriate customer or regulatory follow up.
• Conduct interviews, choose, endorse, recruit, educate, and oversee designated personnel; guide the team and contribute to the probing and solving of issues, assess staff performance, and offer guidance and mentorship to employees. Initiate HR actions including promotions, relocations, dismissals, or disciplinary steps. Assess present and future staffing needs; formulate and execute staffing strategies and associated financial plans.
• Act as a representative for Jubilant in dealings with federal and state regulatory bodies, serving as a liaison; Guarantee adherence to the Board of Health's standards, as well as those of any other state, local, or federal entities (such as the FDA) that have regulatory oversight over the organization's activities.
• Produce reports that highlight non-compliance issues within the nuclear pharmacy; Consult with Operations - Regional Operations Directors to address these discrepancies; Suggest disciplinary actions for repeated instances of non-compliance and ensure the implementation of corrective measures in the nuclear pharmacy through collaboration with the Pharmacy Manager and Operations management; Address inquiries and rectify problematic issues.
• Conduct thorough research to stay abreast of FDA regulatory changes, especially those affecting compounding nuclear pharmacies, and oversee the coordination of compliance research by staff. Delve into new and evolving rules and regulations, with a particular focus on those pertaining to specialty compliance issues in the nuclear pharmacy sector, as well as broader compliance matters. Update and revise policies and procedures to reflect new or modified regulations, ensuring these updates are effectively integrated and implemented across the organization.
• Participate in industry related Associations, Boards, Universities, etc. to keep up to date with the pulse of the profession and to also represent Jubilant Radiopharma as an industry leader and participant. Collaborate with cross-functional teams, including R&D, operations, and supply chain, to integrate quality considerations into product development and manufacturing processes.
• Provide clinical pharmacy support to the pharmacists as requested.
• Participate as a member of the Corporate Compliance Committee; Advise Committee on the current state of compliance within the organization, outstanding issues and recommendations for resolution;
• Manage the process of obtaining and/or renewing Board of Pharmacy licensure for the organizations various facilities.
• Participate in any variety of meetings and work groups to integrate activities, communicate issues, obtain approvals, resolve problems, and maintain specified level of knowledge pertaining to new developments, requirements, policies, and regulatory guidelines.
• Performs other related duties as assigned

Requirements:

• Bachelors of Science or equivalent and 5-7 years' experience in quality management roles within the pharmaceutical or radiopharmaceutical industry, with a strong preference for experience in nuclear pharmacy and radiopharmaceutical diagnostic and therapy landscape
• Have worked in or have been responsible for overseeing QA/QC compliance program required.
• Appropriate training and experience in patient safety requirements of pharmacy operations and experience in performing compliance audits.
• Knowledge of radiopharmaceutical compounding and dispensing experience is desired.
• In-depth knowledge of BOP regulations, cGMP standards, and FDA guidelines related to compounding pharmacies and radiopharmaceutical production.
• Ability to establish priorities, work independently, and complete necessary work functions with a minimum of supervision.
• Proven track record of successfully managing quality systems and leading quality improvement initiatives.
• Strong leadership skills with the ability to manage and motivate teams across multiple sites.
• Strong verbal communication skills and demonstrated ability to work effectively with team members across various operational groups
• Strong technical writing skills and ability to develop, and implement policies and procedures related to Quality, employee and patient safety, radiation safety and pharmacy dispensing;
• Ability to develop, organize and facilitate training both on-site and remotely through use of media.
• Willingness to travel to facility locations as needed.

Qualified candidates please begin the application process by clicking the "apply" button at the top or bottom of this page or go to

Jubilant Radiopharmaciesoffers a competitive salary and benefits package, non-nuclear pharmacist training, relocation assistance and the opportunity to work for the fastest growing radiopharmaceutical company in the nation.

If qualified individuals with a disability need assistance in applying for this position, call Human Resources at informing us regarding the nature of your request and providing your contact information.

AA/DFWP/EOE –M/F/Individuals with Disabilities/Protected Veteran

Job Type: Full-time

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