Boehringer Ingelheim Medical Compliance Vendor Liaison 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 quality management and compliance oversight for US BI (BIPI) clinical trials involving the outsourcing of BI internal functions, and in select cases for the sourcing of specialized services as well. The Medical Compliance Vendor Liaison function will assist in building in quality oversight and effective vendor management principles into Medicine including tracking of CRO Key Performance Indicators across trials to ensure appropriate and timely corrective and preventative plans are implemented and carried through to resolution.
This position will be a resource to clinical/ project teams conducting such trials as well as the holder of associated clinical processes. This position will liaise with Local Global Sourcing Medical (LGSM) and Clinical Trial Contracting Management (CTCM) as needed, as well with Global Vendor Management functional team in business functions and Quality Medicine, to ensure quality management and compliance is maintained and supported throughout the contracting process. This function will support the ongoing interactions between clinical/project teams to address quality and compliance issues. In addition this position will serve as a resource to the clinical/project teams in facilitating the development of Corrective and Preventative Action Plans (CAPA) in the event non-compliance issues arise for specific trials.
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:
Lead the development of establishing a robust end-to-end quality oversight model and effective vendor managements and principles. Drive the activities and projects in Quality Medicine under the direct supervision of the Head of Medical Compliance.
In collaboration with Corporate and local GSM personnel assure adherence to applicable Corporate and local SOPs, BI Quality Manual, WIs, policies, guidelines and regulations.
Drive the root cause analysis on vendor quality events (as well its follow up) by closely interacting with vendors partners to address adequate corrective and preventive actions on CAPA Plans.
Develop, implement and maintain internal processes within BIPI Medicine & QRPE to standardize and support activities to ensure compliance when outsourcing BI internal (core) functions as well as sourcing of specialized (i.e. non-core function) needs. Processes may involve review and approval of trial outsourcing plans, the documentation of transfer of regulatory obligations, vendor compliance and pre-qualification assessments, project governance plans, definition and description of process interfaces across impacted functions, budget review and vendor evaluations.
Act as a vendor management SME by attending departmental, staff and any other meeting where vendor compliance (including performance) input is advisable. In addition, prepare and present selected topics identified as trends, critical and major vendor quality events, information sharing, processes updates, etc. Act as an Inspection coordinator for health authority inspections at BIPI, facilitating the interactions between inspector, vendor representative (if applicable) and BI. Provide feedback and guidance on inspection preparation activities where vendor is involved.Act as a vendor management SME by attending departmental, staff and any other meeting where vendor compliance (including performance) input is advisable. In addition, prepare and present selected topics identified as trends, critical and major vendor quality events, information sharing, processes updates, etc. Act as an Inspection coordinator for health authority inspections at BIPI, facilitating the interactions between inspector, vendor representative (if applicable) and BI. Provide feedback and guidance on inspection preparation activities where vendor is involved.
Lead the assessment of activities pertaining to contracting with niche vendors to support Digital Health /Medicine efforts. Provide training to BIPI Medicine as needed regarding outsourcing processes and best practices especially in the areas of quality management and regulatory compliance.Lead the assessment of activities pertaining to contracting with niche vendors to support Digital Health /Medicine efforts. Provide training to BIPI Medicine as needed regarding outsourcing processes and best practices especially in the areas of quality management and regulatory compliance.
Develop tools to manage and report specific information regarding the outsourcing and outside vendor requests and ongoing vendor-related activities of all clinical trials/projects conducted at BIPI as well as in support of departmental outsourcing as agreed by management.
Assure that mechanisms are in place to secure compliance and that tracking mechanisms are in place, including use of KPIs, to address issues that may arise assuring that corrective actions have been implemented and reported. Coordinate, perform and report Vendor Quality Visits utilizing a risk based approach coordinated with CQA Vendor Auditing, Project Teams and management as appropriate.
Requires a Bachelor’s degree with five (5) to seven (7) years’ experience in clinical trial operations and GxP Compliance required; or equivalent experience of nine (9) to eleven (11) years.
Ability to operate independently of functional groups and provide critical independent assessments and advise to senior management.
This position also requires strong analytical skills as well as demonstrated strength in agility while demonstrating initiative and ability to develop and implement a new process.
In addition, requires exclusivity of responsibility, strategic and operational processes conceptual/Analytical Thinking, internal accountability, organizational design, initiative and self-motivation.
The position requires the ability to understand/interpret/coordinate quality and performance improvement activities, perform data collection and reporting, and support compliance and risk management activities. In addition the position requires the ability to construct a quality management vendor oversight model which encompasses vendor assessment, qualification, performance and issue management through KPI/KQIs measures.
Direct experience working in a matrix model and previous experience working at a Clinical Research Organization is strongly preferred.
Must be familiar with FDA Regulatory requirements and ICH/GCP. Familiarity with EMA and/or other Regulatory requirements.
Extensive clinical regulatory compliance and GCP experience in the pharmaceutical industry needed to support BIPI policy and strategy on quality related issues and processes improvement.
Additional experience with trials with outsourced components and a business financial orientation or experience is desirable.
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 be able to execute defined objectives with limited direct supervision.
Moderate skills in standard business applications (Word, Excel, and Access) required.
Must be legally authorized to work in the United States without restriction.
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 one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. 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. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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 verifications and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Medical Compliance Vendor Liaison
Location: Americas-United States-CT-Ridgefield
Requisition ID: 188626