The Senior Associate Director, Compliance Management supports Medicine business functions to ensure compliance with regulations and guidelines and to continuously improve their processes and deliverables. The Sr. AD, Compliance Management is assigned per therapeutic area in order to support clinical development teams with trending and analysis, risk assessments and inspection readiness. They give GxP compliance consultancy to Medicine business functions as needed. The Sr. AD, Compliance Management supports global quality initiatives and compliance topics as assigned.
The Sr. AD, Compliance Management develops best practices for compliance processes considering outside and inside view striving for innovation, effectiveness and efficiency.
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
Acts as cross-functional compliance expert
Provides GxP guidance as required
Ensures sharing of best practices within QM and Medicine business functions as applicable
Initiates updates of relevant process descriptions and guidelines as needed
Supports global quality issues, compliance topics and improvement initiatives
Supports the teams in order to perform a sound root cause analysis and to identify adequate CAPAs
Ensures adequate effectiveness checks after implementation of actions
Supports the teams with respective Quality tools and methods
Offers process analysis and optimization capabilities as applicable
Defines and implements strategy for support of clinical development projects.
Supports clinical development teams with trending and analysis; gives recommendations based on risk assessments for continuous improvements; supports teams in compliance questions and global improvement initiatives as applicable.
Defines and delivers training for NC/CAPA process and other compliance topics as applicable
Supports IDE projects (In-Depth Evaluation and Due Diligence Process) by assessing GCP compliance.
Supports Partnering projects when BI's GCP compliance is assessed by external potential future partners.
Bachelors OR Master’s degree from an accredited institution
Eight plus (8+) years’ experience in GxP quality management systems
Minimum of twelve (12) years in pharmaceutical / CRO industry
Minimum of seven (7) years’ experience in Clinical Operations and/or other BI Medicine functions
Minimum of five (5) years’ experience in Non-Compliance (NC) and Corrective Action / Preventive Action (CAPA) management processes, incl. Root Cause Analysis methodologies
Strong organizational and project management skills
Proficient knowledge in applicable regulations, company processes and procedures with ability to assess their impact
Experience in interacting with Regulatory Authorities e.g. regulatory inspections
Strong interpersonal, cultural and communicational 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.