Quality Assurance & Standards Manager – Patient Specialty Services job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. It is a pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of this makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.|
The Quality Assurance & Standards Manager supports/leads the overall Quality Assurance activities for all P&SS Patient Support programs in designing and monitoring Quality management systems that will optimize Compliance including HUB, field, Adherence, Copay and Specialty Pharmacy programs
Ensure the Quality principles, policies and procedures are engrained in routine activities of the Patient & Specialty Services organization.
Work with P&SS Patient Support Program vendors to maintain Quality Assurance systems/processes, which include but are not limited to routine monitoring calibration sessions to ensure meeting regulatory standards.
Lead Quality/Compliance activities for new product launches to insure all content is compliant with regulatory guidelines and NPC policies.
Ensure all PSP vendor partners are current on the mandatory NPC training curricula
Liaise with Drug Safety & Education (DS&E), Patient Oriented Programs (POP), Legal, Privacy and
Compliance to ensure accurate reporting of Adverse Events (AE) by PSP vendors and P&SS team
Review Task Orders (contracts) to provide Quality/Compliance oversight
Ensure quality programs are quantifiable with success metrics
Implement training programs that addresses Quality and Compliance policies and requirements relevant to specific roles within each P&SS function.
Continuously evaluate, to identify opportunities in area of Quality/Compliance systems and standards including remedial action plans and tracks resolution.
Assist in internal and external audits including any remedial Corrective and Preventative action plans and routine monitoring to ensure completeness per established timelines.Bachelor's Degree
Professional experience in the field of Quality Assurance (8 years minimum)
At least 5 years of experience within the regulated pharmaceutical industry and knowledgeable of current related regulations
At least 7 years of progressive business experience in the biopharmaceutical industry with broad understanding of pharmaceutical sales, marketing, reimbursement and patient services
Demonstrated "hands-on" understanding of the current compliance environment including current regulations and standards from the FDA, CMS, HHS OIG, and other regulatory and enforcement agencies
Prior experience in quality monitoring/auditing of patient services programs
Ability to identify opportunities for continued improvements and drive their implementations across the organization.
Experienced in audit related activities both internal and external.
Knowledgeable on effective Quality documentation systems.
Strong communication & negotiation skills
Experience in project management, planning and organization.
Ability to work effectively as an individual contributor and in a team structure; maintain strong cross-functional ties with key business partners.
Strong collaboration, communication and team facilitation skills.
Willingness to travel, sometimes at short notice; travel time up to 25%