Apr 19, 2018
As one of the world's leading pharmaceutical companies, our business is focused on providing innovative, effective medicines that make a real difference in important areas of healthcare. At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organization by maintaining a culture in which our people feel valued, energized and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business. And we support and encourage our people in discovering their own potential, through excellent learning and development opportunities that are available to them throughout their careers.
The AstraZeneca Information Center (IC) responds to unsolicited requests from customers by providing focused, non-promotional and on-label responses which are free of medical advice. Customers include physicians, pharmacists, nurses, physician office staff, consumers, patients, and AZ field representatives. Contact channels include phone, e-mail, fax, and postal mail. The IC has outsourced front-line handling of customer inquiries to vendor partners, who follow IC processes and use IC systems.
As the Information Center Training and QA Manager you will be responsible for leading the analysis, design, development, control, implementation, delivery, documentation and evaluation of training and education for the IC staff, for creating new training content and processes and using Learning Management systems.
While in this role you will also be responsible for leading, managing and developing a team of Quality Assurance (QA) and Business Specialists. In collaboration with the AZIC Product Quality Complaint (PQC) Liaison and US Market Company Complaints Process Owner, the Training and QA Manager will contribute to the oversight of the Product Quality Complaint (PQC) review and processing, and oversee the ownership, development and execution of the customer service processes.
Main Duties and Responsibilities
+ Leads, manages, coaches, and develops a team of IC Quality Assurance Specialists, and Business Specialists, to ensure the effective and efficient delivery of work in alignment with all objectives and timelines. Sets/confirms prioritization of tasks and assigns resources to projects. Ensures necessary training is in place for Specialists and is responsible for their performance management.
+ Leads the analysis, design, development, control, implementation, delivery, documentation and evaluation of training and education for the IC staff, which includes both IC employees and vendor partner staff.
+ Identifies IC training needs and creates plans to address these gaps. Coordinates with other areas of the organization to ensure that existing training resources are leveraged. Coordinates with IC Medical Program Managers to ensure appropriate medical training is provided to the IC medical staff.
+ Leads and manages the creation and approval of new training resources.
+ Leads and manages the Saba Cloud / Learning Gateway Learning Management System training processes, including curriculum development, assignment and completion.
+ Oversees IC employee and vendor partner staff adherence to training requirements, including IC and AZ Compliance training and evidence of staff training completion, in order to ensure inspection readiness.
+ Identifies and evaluates training resources to support employee development.
+ Conducts training at vendor partner sites, and contributes to vendor partner oversight.
QA and Business Process Management
+ Coordinates IC QA and Business teams and assists in resolving issues and providing solutions relating to programs being executed, and future programs.
+ Provides QA and Business status reporting across programs, including issue and risk management, to the Information Center Director, and others.
+ In collaboration with the AZIC PQC Liaison and US Market Company Complaints Process Owner, contributes to the oversight of the US Product Quality Complaint (PQC) process to ensure consistent, clear, effective, and timely identification and communication of all PQCs to the appropriate investigation supply sites.
+ Manages the US Market Company Complaints Process Owner’s oversight of compliance to all QA Standard Operating Procedures (SOPs).
+ Ensures integration across the organization by leading IC QA Specialists in developing and maintaining appropriate and effective liaison relationships with global supply sites and functional areas such as Quality Assurance, US Operations and Patient Safety, as necessary.
+ Leads IC QA Specialists in providing direction and support for PQC process to team for new distribution deals, product launches and new partners. Oversees execution and management of projects, pilots and other initiatives in support of supply sites, Operations and Commercial goals.
+ Remains current with evolving regulatory compliance and quality practices related to PQCs.
+ Oversees IC promotional support and customer service programs, updating the knowledge management database and planning, management and execution of IC business initiatives.
+ Builds and maintains effective liaison relationships with key internal stakeholders.
+ Creates and maintains IC processes and procedures, including Customer Resource Documents (CRDs), to ensure that the IC knowledge base remains up-to-date with consistent, comprehensive and accurate content.
+ Complies with all industry regulations, and policies and procedures of AstraZeneca and the IC.
+ Identifies, develops, and implements best practices.
+ Continuously seeks and drives opportunities to improve processes and performance of individuals, and reduce department risk. Champions the needs of the department by proactively recommending and contributing to the creation and implementation of improvements to IC processes and initiatives, and to mitigation of risk.
+ Bachelor’s Degree in communications, business, healthcare-related, science / technical field or relevant experience
+ 2+ years experience leading teams in a supervisory role and managing projects
+ Strong demonstrated ability in leading and managing teams and ability to effectively advocate the team’s position to various stakeholders
+ Strong project management experience, exemplary compliance ethics, high concern for standards, strong strategic and analytical thinking, and strong negotiation and facilitation skills
+ Experience in training, curriculum design, and delivery
+ Strong knowledge of Product Quality Complaint intake and processing, GMP, Quality systems, and the pharmaceutical supply chain environment
+ Excellent oral and written communication skills
+ Strong ability and motivation to learn and keen ability to stay current of relevant factors in the evolving/changing pharmaceutical environment
+ Excellent customer service, teamwork, collaboration, interpersonal, analytical, and organizational skills with proven experience working in a team-based environment
+ Demonstrated ability to manage multiple priorities
+ Demonstrated understanding of healthcare legal/regulatory requirements and corporate policies and guidelines
+ Demonstrated competency using information technology, PCs, and databases
+ Demonstrated ability to synthesize and integrate varied needs and perspectives with proven results
+ Must be available to work 7.5 hours/day between the hours of 8am to 6pm, Monday through Friday
+ Must be able to travel via commercial airline
+ Advanced degree in science or training, or Bachelors degree and current medical license in nursing or pharmacy
+ 2+ years’ experience working in a contact center environment
+ 2+ years relevant experience in a pharmaceutical or medical device organization
+ Demonstrated ability to provide medical and business information and customer service to health care professionals and consumers
+ Experience working with technology capability and enablement projects
+ Experience working with Learning Management System(s)
+ Demonstrated understanding of AstraZeneca’s business model
+ Familiarity with US healthcare system
Next Steps -- Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Wilmington, DE, USA