About this opportunity
Boehringer Ingelheim lists this Sr. AD, Quality & Compliance Lead (Hybrid) opportunity in ridgefield, Connecticut. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
The SR AD, US Quality and Compliance Lead (QCL) is the Quality and Compliance expert and drives GvP / GcP topics across the BI organization to proactively manage Quality and Compliance across the drug/device lifecycle. This role leads the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity. The position holder initiates and manages any quality and compliance topics to continuously improve our Quality Management System.
Duties & Responsibilities
The SR AD, US QCL provides quality and compliance consultancy to enable fast and efficient research and development, market authorizations and maintain licenses for our portfolio of products within BI US. This role contributes US insights into the Global Quality Medicine Strategy and executes the strategy at US level with the ability to act locally and think globally
Develops and maintains the global Quality Management System and tailors to the US OPU to comply with local regulatory requirements.
Is a quality & compliance consultant and works collaboratively as a solution oriented, pragmatic partner to the Medicine functions and other applicable business partners, leading them to understand the quality and compliance requirements and implications for their business area
Leads the understanding of Quality Culture by ensuring quality and compliance standards are understood and embedded into processes and practices early (Quality by Design)
Leads FDA and other global or local authorities inspections end to end (inspection preparation, conduct and post inspection management), representing the BI compliance position to regulatory authorities during inspections ensuring inspection findings are addressed and responses provided
Contributes holistic Quality and Compliance input as a Project Quality and Compliance Lead (PQCL) at the project/trial level, provided appropriate qualification is available and under the oversight of global
Leads with the Head of QM the preparation of Quality Management Review reports and meetings
Actively collaborates in the set-up, development and implementation of quality objectives and Quality plans
Deputize for the US Head of QM where applicable
Assesses impact of Regulatory Intelligence Network (RIN) changes on Quality and Compliance processes and acts and escalates topics accordingly
Responsible for active involvement and participation in local/ global/regional activities/topics and projects
Leads the implementation and maintenance of global procedures in a pragmatic, clear and concise way and ensure adherence to the local regulatory and business requirements
Collaborates with Experimental Medicine and BU Medicine functions in conducting US learning needs analysis (training, qualification)
Communicates global changes into US as required to enable adoption of the new ways of working
Verifies translation of relevant topics as required
Initiates updates of relevant process descriptions and guidelines as needed
Ensures lessons learned are implemented
Contributes to audits by inputting into the annual audit planning and ensures audit findings are appropriately investigated and actions are effectively implemented
Conducts audit activities as lead-; co- or BI responsible auditor provided appropriate qualification is available, upon request (assignment) and under oversight of the global auditing leadership team
Defines requirements for services needed by US in collaboration with Medicine Function
Responsible for management and oversight of suppliers effectively within US liaising with Global Suppliers Quality and Compliance Manager stakeholders (e.g. Medicine, Sourcing, Legal and Commercial Quality) from site qualification to the process end and Non-Compliances/Corrective Action / Preventive Action (CAPA) Management
Performs periodic review of US specific suppliers
Continuously reviews and evaluates standards and processes for potential compliance gaps/risks/near misses in accordance with regulatory and legal requirements
Provide quality analysis, trending and optimization capabilities across Medicine Functions
Requirements
Minimum of Bachelor's degree required; Advanced degree (PharmD, Ph.D., Master’s), preferred
Minimum eight (8) years proven GCP depth, experience with inspection management required (lead or support role)
Knowledge
QM processes and functional processes: level of understanding such role can provide appropriate Quality and compliance related advice in relation to the QM processes
QMS: understanding of the sub-elements of QMS and how they link together such that role can fulfil QMS related accountability (see above)
Quality by Design: in depth knowledge of QbD approaches such that role can provide appropriate QbD related advice in relation to QM and functional processes
BI organization & strategy: understand the BI organization and our goals such that role can incorporate these topics whilst delivering accountabilities e.g. considering strategy and goals when providing advice within (R)OPU
R&D understanding: understand overall drug development process and BI specific areas of focus (therapeutic areas) such that role can incorporate these topics whilst delivering accountabilities
Digital suppliers: understand digital suppliers such that role can incorporate these topics whilst delivering accountabilities e.g. provide advice on risks to data integrity through use of specific supplier and suggest ways to mitigate these risks
New technologies: knowledge of specific technologies e.g. data collection technologies and the associated (potential) regulations, such that role can provide advice in their use within the (R)OPU
External regulations: knowledge of the relevant regulatory requirements for QM and functional processes to be able to assess the risks for non-adherence to external regulations and provide mitigation strategies or how to address issues
Skills
Communication skills: able to communicate effectively clearly and concisely with all individuals across BI regardless of their position or relationship
Influencing & negotiating skills: able to clearly articulate options and their potential implications and reach an agreement with all individuals across BI regardless of their position or relationship
Leadership skills: able to lead Quality and Compliance topics and teams (including matrix or project teams) effectively to deliver the responsibilities effectively
Data analytics: able to perform simple analyses and interpretation of data to enable decision making and to identify recommendations
Critical thinking: able to draw reliable conclusions to make decisions or recommendations
Presentation skills: able to design and deliver effective presentations to achieve the required outcomes
Risk management: able to identify and manage risks effectively
Project management: able to apply project management techniques to lead and deliver local or regional projects
QM Behaviors
Ability to adopt and incorporate QM expected Behaviors into how role delivers its accountabilities including: being pragmatic, solution oriented, collaborative, customer focused, proactive, assertive and decisive
Ability to travel regionally and internationally as needed
Eligibility Requirements
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
Compensation
The base salary range for this position is $170,000 to $269,000. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here .
Our Company
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
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Worksite address
ridgefield, CT, 06877, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.