The basic purpose ofthis position is to provide technical direction and serve as a subject matterexpert (SME) for product disposition activities to assure that Quality systemsand processes are in place. Also, be anSME for the documentation of the deviation, root cause analysis, CAPA, andimpact assessment of the event. Responsible for implementing procedures to assure compliance with EU,USDA, and corporate requirements; and ensuring final investigation reports meetregulatory and BIAH requirements. Thisposition will indirectly support the Quality and Compliance departmentaccording to company policies and corporate business plans and to providetechnical support to QA Release functions. Participate and helps lead regulatory inspection. This position also serves as a deputy(backup) to the Sr. Associate Director in the event of their absence.
As an employee ofBoehringer Ingelheim, you will actively contribute to the discovery,development and delivery of our products to our patients and customers. Ourglobal presence provides opportunity for all employees to collaborateinternationally, offering visibility and opportunity to directly contribute tothe companies' success. We realize that our strength and competitive advantagelie with our people. We support our employees in a number of ways to foster ahealthy working environment, meaningful work, diversity and inclusion, mobility,networking and work-life balance. Our competitive compensation and benefitprograms reflect Boehringer Ingelheim's high regard for our employees.
- Responsible for tracking and reporting status of all action items on a routine basis to assure Quality systems are in place to support the business across sites during company acquisitions and divestures.
- Assures all site processes are in place to support the business. Review and approve laboratory and manufacturing investigations to ensure compliance with BIAH policies and applicable regulatory guidance. Coordinate investigations across all functions within operations, ensure effective root cause analysis, and develop corrective and preventive actions for associated events relating to biological production operations and associated quality systems. Ensure timely completion of investigations per procedures and the implementation and completion of corrective and preventive actions.
- Completes all assigned training by target due dates as assigned by BIAH.
- Assists in development of training plans and trains others, including training outside of area of responsibility.
- Assists as needed in development and maintenance of training curricula.
- Indirectly supports the following Quality & Compliance activities as needed:
- Change Control
- Regulatory Activities
- QA management activities, including staffing, budget, compensation, KPIs, strategic planning.
- May have Management Responsibilities to include:
- Manages department expenses.
- Communicates staffing expectations to applicable QA staff.
- Develops assigned direct reports.
- Identifies equipment/tools needed for QA Release.
- Provides input for performance reviews and compensation approvals.
- Performs data generation & provides reports/updates for Quality Management reviews
- Performs business and strategic planning for area of responsibility in alignment with Company objectives
- Bachelor's degree from an accredited institution in a scientific discipline or relevant field.
- A minimum of ten (10) years of strategic experience in QA systems and processes including deviation management within in a GMP regulated manufacturing facility or similar environment. Experience must be inclusive of six (6) years leading people, projects and leaders.
- Preferred regulatory experience in FDA and/or EU regulated environment.
- Sterile product manufacturing experience preferred.
- Must be able to handle multi tasks and provide the leadership to implement solutions to complex problems using the best available technology.
- Change management experience is critical for this position, including successful leadership of organizational transformation within relevant QA functions.
- Demonstrated ability to use technical knowledge to solve problems.
- Proficiency in relevant computer software and programs associated with the organization to detail and commitment to customer service.
- Requires the ability to utilize computer programs such as Microsoft suite, GoTrack, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.
- Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH’s excellent reputation in the community.
- Basic understanding of EU GMPs, Outlines of Production, 9 CFR and compliance requirements is required for this position in order to properly assess product, procedures, recommend/drive improvements and make correct decisions.
- 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
Who We Are:
At Boehringer Ingelheim we create value through innovationwith one clear goal: to improve the lives of patients. We develop breakthroughtherapies and innovative healthcare solutions in areas of unmet medical needfor both humans and animals. As a family owned company we focus on long termperformance. We are powered by 50.000 employees globally who nurture adiverse, collaborative and inclusive culture. Learning and development forall employees is key because your growth is our growth.
Want to learn more? Visitboehringer-ingelheim.com andjoin us in our effort to make more health.
BoehringerIngelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., BoehringerIngelheim USA, Boehringer Ingelheim Animal Health USA Inc., BoehringerIngelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont,Inc. is an equal opportunity and affirmative action employer committed toa culturally diverse workforce. All qualified applicants will receive considerationfor employment without regard to race; color; creed; religion; national origin;age; ancestry; citizenship status, marital, domestic partnership or civil unionstatus; gender, gender identity or expression; affectional or sexualorientation; pregnancy, childbirth or related medical condition; physical orpsychiatric disability; veteran or military status; domestic violence victimstatus; genetic information (including the refusal to submit to genetictesting) or any other characteristic protected by applicable federal, state orlocal law.