Boehringer Ingelheim Director, US Medical Compliance 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.
The Director, US Compliance is responsible for driving the implementation of robust GXP Quality Management System and Processes for all regulated areas pertaining to the US Medicine Organization executed within the US OPU.
Ability to facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and improvement initiatives within the US OPU organization.
Ability to share/ implement vision and strategy within the Compliance organization and to the business functions across US Medicine organization.
Collaborate and contribute across corporate/global functional areas on corporate processes for improving efficiency by optimizing processes necessary for continuous improvement.
Responsible for developing real-time feedback mechanism related to Medicine quality analytics which will allow for critical feedback and trending to be shared with key stakeholders in support of critical decision making and mitigation recommendations.
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
Provide strategic and tactical leadership across the Compliance organization and set overall direction for the goals and objectives across the US.
Create a performance based culture by leading by example.
Setting clear and robust roles and responsibilities, accountability and sense of urgency for achieving results;
Champion and establish a proactive "quality-centric" culture which focuses on prevention and risk assessment approaches;
Recruit, hire, coach, develop, motivate, manage, and monitor performance and set job expectations, provide regular feedback, conduct timely performance reviews, identify performance challenges.
Member of US Quality Medicine Leadership Team
Lead US compliance managers and vendor compliance managers;
Leads project initiatives within the Quality organization. Serves as subject matter expert in Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) and act as a contact for internal and/or external stakeholders.
Ensure Leadership oversight of key country specific initiatives/ inspections/continuous improvement efforts that could link to global programs. Ensure proactive communication to the relevant key stakeholder across Quality Medicine and relevant business functions.
Oversight of US related regulatory inspection preparation, management and follow-up in collaboration with business functions, and support US inspections specifically when Medicine Functions are deemed in scope.
Develop "inspection readiness" awareness across US Quality Medicine in collaboration with global and across business functions
Evaluates and monitors Health Authorities’ interpretation and application of their regulations and guidance, and changes in this interpretation / application over time. Works closely with the Head of Inspection in assessing risk/opportunities associated with the US Health Authorities, as applicable.
Ability to manage risks and proactively address key mitigation strategies with the relevant business functions. Ensure proper escalation of risks and mitigation strategies to line management.
Ability to communicate trends related to audit findings, non-compliance, vendor oversight, issue management across key stakeholders to drive actions as well as continuous process improvement/training opportunities
Bachelor’s degree from an accredited institution in a scientific discipline with minimum of twelve (12) years or Master’s degree from an accredited institution with minimum of ten (10) years’ experience.
Advanced knowledge and GCP experience in the pharmaceutical industry needed to identify and analyze complex GCP issues.
More than six (6) years leadership and project management experience
International business exposure
A broad range of compliance experience/demonstrated experience in a senior advisory role.
Expert knowledge of regulatory requirements in the area of GCPs, ICH guidelines, FDA regulations and BI procedures.
Ability to operate independently of functional groups and provide critical independent assessments and guidance to senior management.
Broad knowledge of requirements surrounding validation of computerized systems (specifically 21 CFR Part 11).
Ability to communicate clearly and effectively in writing and verbally, demonstrate excellent interpersonal skills, lead and work well in teams or independently, possess the ability to influence and negotiate with excellent judgment and decision making qualities, and able to multi task and manage time efficiently and effectively. Strong organizational and prioritization skills, good analytical and problem solving skills.
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: Director, US Medical Compliance
Requisition ID: 1814550