Boehringer Ingelheim Sterility Aseptic Process Assurance Specialist in SAINT JOSEPH, Missouri
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.
Lead and coordinate Quality for aseptic processes and Compliance within all manufacturing sites to ensure that all products are developed, manufactured and released in compliance with the company and regulatory requirements. Defines the BIAH Quality policy in his/her scope of responsibility (Sterility/Aseptic process expertise), coordinates its implementation across the group by ensuring compliance with company, Global BI and regulatory requirements. Contributes to the implementation and management of Quality Systems on one/several specific domains, by providing technical support to users/sites.
This position will be located at one of our BI Animal Health locations. Some travel required (up to 30%) to our other BIAH locations.
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:
Defines the BIAH strategy for his/her scope of responsibility, in a regulatory environment in constant evolution.
Ensures alignment of the BIAH System with the evolution of regulations, through a permanent dialog with agencies and other industries.
Ensures the implementation of BIAH Quality Policy in his/her scope of responsibility, covering the full life-cycle of all products.
Provides direction to Quality Operational Units for deploying the processes, consistently with up to date regulatory requirements and company directives.
Defines and implements approaches and tools for his/her perimeter to enhance consistently an early risk identification and their prevention, as well as compliance quality expectations.
Supports training actions to deploy the policy, tools and systems in his / her perimeter.
Provides technical support for the implementation and contributes to quality projects and/or quality systems (Collecting and handling data, User support, Validation & Documentation).
Contributes to the maintenance of the quality tools in his/her scope of responsibility.
Provides technical support in the frame of trouble shooting by contributing/leading root cause analysis, investigations and corrective actions implementation.
Contributes to tool improvement process according to users’ needs.
Participates in training for users.
Participation to BI working group to define veterinary position.
Participation to inter-company working Group in order to represent BIAH position (in accordance with BI rules).
Prepare and support regulatory inspection for injectable/sterile products
Veterinarian, Pharmacist or Physician, a graduate level degree from an accredited institution in the life sciences, or a combination of education
At least 10 years of professional experience in Quality management within a Pharmaceutical company working under FDA, USDA, EU GMP and other major countries regulations at a senior level.
Deep knowledge in various technologies, both in Pharma (sterile products) and Bio (biogenerators, monolayers, ovoculture)
Expert in Sterility Assurance including RABS and Isolators
Good knowledge of EU, FDA and USDA Regulations
Leader for all Quality/Compliance issues, practices and behaviors
Strategic vision and leadership, influencing and negotiating skills with top managers within the Company and with various Agencies heads and representatives at worldwide level, i.e. with various cultures
Broad management experience of large mixed teams including senior scientists, veterinarians, pharmacists, including remote teams
Excellent communication 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.
Title: Sterility Aseptic Process Assurance Specialist
Location: Americas-United States-MO-Saint Joseph
Other Locations: Americas-United States-GA-Athens, Americas-United States-GA-Gainesville, Americas-United States-GA-Duluth
Requisition ID: 189310