Boehringer Ingelheim AD, Vendor Quality Management in RIDGEFIELD, Connecticut
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
To provide strategic project planning, quality management oversight and internal process foundations for BIPI contact center vendors involving the recognition, collection and communication of medical related data (specifically, but not limited to Adverse Events) and the outsourcing of BI internal functions. Will liaise with Strategic Sourcing and Relationship Marketing as part of the strategic project management agencies, vendors and contact centers and as part of the overall strategic planning for outsourcing, to assure that there is quality management as part of the contracting process and for overall vendor needs. In addition this position will serve as a resource to cross functional and Medical teams in facilitating the development Corrective and Preventative Action Plans (CAPA) in the event non-compliance issues arise.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Develops and operates a quality monitoring program that utilizes various methods for quality monitoring (i.e. sample monitoring of recorded calls, sided by side, mystery caller, customer survey, etc).
Conducts quality control reviews of adverse events cases of all types(non serious, serious, expedited) report findings and follows up on resolution of issues to ensure compliance to corporate SOPs and FDA regulations.
Involved in facilitating interactions between the contact centers and strategic outsourcing through the outsourcing process including vendor needs assessment, outsourcing strategy, internal approval and vendor technical/regulatory assessment.
Assures adherence to applicable Corporate and local SOPs, WIs, policies, guidelines and regulations.
Responsible for modifying and creating local WIs and workflow processes and templates as appropriate.
Develop and maintain expertise in outsourcing best practices, options and strategies
Periodically audits contact center vendor partners for adherence to contract, regulation, service agreements and BI policies. Assures that all aspects of the relationship (technical, operational, legal and financial) are defined and adhered to.
Continuously evaluates, communicates impact of programs to company as well as records the outsourcing and outside vendor needs of contact centers at BIPI.
Assure that mechanisms are in place to secure compliance and that tracking mechanisms are in place to address issues that may arise assuring that corrective actions have been implemented and reported. Collaborates with Associate Director of Training on topics for both new hire and refresher trainings.
HCP, Bachelor Degree, advanced degree or related field or equivalent work experience (required)
Must have three to five years of experience in pharmaceutical industry, either in safety, data management or clinical operations.
2 years contact center experience preferred
Knowledge of contact center operations
Knowledge understanding of BIPI regulations as they apply to drug surveillance particularly for pre- and post marketing adverse event reporting.
Must have exceptional project management, organizational, communication and collaborative skills.
Must be able to lead and organize cross-functional teams and work on multiple projects simultaneously.
Must possess demonstrated supervisory, analytical and teaching skills and the ability to multi task and organize time effectively.
Must be able to execute defined objectives with limited direct supervision.
Moderate skills in standard business applications (Word, Excel, and Access) required.
25% travel to vendor partners to conduct audits, side by side monitoring, service agreement reviews, etc.
1 to 3 years of leadership experience
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Organization: US-BI Pharma/BI USA
Title: AD, Vendor Quality Management
Location: Americas-United States-CT-Ridgefield
Requisition ID: 184837