Director, GI Quality
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 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 several 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.
The Director, GI Quality sets the strategic direction for quality objectives and directives based on the Global GI Quality priorities. This role is responsible for Quality and Compliance per BI and relevant Health Authority regulations for all GI sites in the region. The incumbent ensures processes are defined and executed in accordance with current GXP, BI Regulations, and other relevant regulatory requirements across sites.
This role provides strategic direction to GI Quality site leadership across the USA sites. Represent Global AH GI Quality on cross-functional leadership teams in the region responsible for AH GI priorities. This includes ensuring relevant quality and compliance requirements are maintained with adequate oversight of GI functions in the region according to global and divisional procedures.
The Director, GI Quality will ensure execution of strategic objectives at the GI sites in close collaboration with the GI Site Quality Heads, GI Development Quality and GI Clinical Quality team. The incumbent provides strategic leadership to and/or contributes to specific Global AH (GI) Quality projects. This role is responsible to drive continuous quality improvement and support the development of the Quality Culture within BI. The incumbent leads projects as assigned, assumes Divisional (GI) MSO (if nominated), and ensures implementation of the respective Quality System throughout the global AH sites.
Duties & Responsibilities
• Acts as overall Quality Responsible for the region and resolves quality issues escalated from GI Sites in the US.
• When necessary, escalates issues to the Global Head of GI Quality to resolve conflicts promptly and minimize risk to BI.
• Ensures appropriate internal awareness, escalation to Global AH Quality and accurate, timely authority reporting.
• Provides strategic leadership to GI Site management teams.
• Provides strategic leadership to GI Quality teams at the sites in the region and ensures Quality systems are in place and quality topics are under control.
• Ensures appropriate and up to date overview of global/divisional procedures implementation at the local GI sites are available.
• Ensures appropriate quality input and support for business projects, e.g., major GI capex projects.
• Implements local, divisional and Corporate Quality strategic direction (e.g., quality risk management, quality road maps, quality operations activities, batch documentation review, lab investigations, change control, deviation management), for continuous improvement and CAPA process.
• Provides appropriate training and support for the preparation and realization of inspections in the sites or units.
• Supports GI US sites in GXP regulatory inspections and global/corporate audits, including a support to define the most appropriate action plan to address the findings pointed out by the investigators/ auditors.
• Participates in the review and approval of Quality organizations of the various entities and participate to the performance assessment of Quality management in conjunction with GI operational management.
• Set goals and expectations of staff.
• Evaluates direct report's core job/MAG performance and contribution to team performance.
• Coaches direct reports on their performance and development as well as provides feedback on core job.
• Complies with relevant BI in house health and safety guidelines and specifications.
• Develops and administers US GI Quality budget to achieve organizational performance objectives in a cost-effective manner.
• Provides technical-regulatory expertise to multidisciplinary projects for new drug products, to review documents to be submitted in regulatory agencies as well as revising the responses to incomplete letters or requirements done by regulatory agencies.
• Supports the GI sites for complex product topics related to research/development/clinical issues.
• Represents Quality for Global Innovation in GXP regulatory and corporate inspections/audits, including support to define the most appropriate action plan to address the findings pointed out by the investigators/auditors.
• Defines implementation strategies for global GI regarding international key GxP standards and updates and ensure compliance at the different GI sites for multiple target markets.
• The domain of GI activities is highly regulated both BI internally and externally (e.g., GLPs, GCPs, GMPs, USP, EP, VICH) from EU, US, China, and other relevant authorities.
• Supports GI quality teams and GI stakeholders on GxP compliance, renewals and projects.
• Maintains a good understanding of the latest regulatory requirements of the countries in scope of AH GI and at the interface to AH GS.
Requirements
• Pharmacist, veterinarian or master of Science in Chemistry, Microbiology or other life science.
• Must possess five (5) years of demonstrated managerial experience in Pharmaceutical organization.
• Minimum ten (10) years operational experience in a pharmaceutical and vaccine quality environment.
• Extensive knowledge of national and international regulations (e.g., VICH, USFDA, FDA, EU, PICS) and their effect on clinical/development/manufacturing and testing of AH products in R&D pipeline.
• Possess thorough working knowledge of current Good Manufacturing Practices and Good Laboratory Practices and Good Clinical Practice as they pertain to Quality Operations required.
• Technical knowledge of pharmaceutical life cycle management (validation, manufacturing, packaging, testing, storage and distribution) and risk mitigation strategies.
• Knowledge and experience of the processes and procedures required to bring pharmaceutical and biological products from research through clinical phase, development until ready to take over for launch preparation (QA, QC, Manufacturing, Regulatory Compliance in an international pharmaceutical company).
• Proven leadership skills (team composition, team building, change management and developing skills).
• Experiences with audits and authority inspections.
• Ability to focus on the "big picture".
• Good knowledge of external GxP regulations.
• Solid oral and written communication skills and interpersonal skills.
• Fluent in English. Ability to work in a strong matrix environment and to network across the company.
• Ability to be a pragmatic and reliable partner for management.
• Ability to develop sound business plans and design strategies, demonstrated negotiation skills.
• Ability to run an external business relationship.
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.
Pharmaceutical Manufacturing
Quality Assurance
Full-time