DescriptionThis is a hybrid position which requires 2-3 days per week onsite at our offices in Ridgefield, CT.
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.
CompensationThe base salary range for this position is $166,600 to $250,000. 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 .
