Responsible for management and implementation of the internal audit program at the St. Joseph location and the BIV-US external auditing programs of raw material & contract manufacturers, laboratories, suppliers, etc. to assure compliance to cGMPs/ICH/BI corporate standards
Responsible for management and maintenance of the BIV-US supplier quality database.
Responsible for development and management of supplier qualification program, compliance to the supplier qualification program, and ensuring the program meets corporate and GMP requirements.
Assemble and provide KPIs to monitor the BIVI supplier quality program and reporting of corporate KPIs on a monthly basis.
May have direct reports.
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\:
Assure GxP compliance of the St. Joseph facility to BIVI and regulatory requirements by managing the internal AH audit program for St. Joseph. Conduct external audits of API, excipient, packaging component, laboratory service, and other GxP-related vendors. Develop and maintain pool of qualified lead auditors. Ensure a compliant supplier quality program for BIVI is maintained.
Develop and implement procedures for managing Supplier Qualification Program according to corporate standards within BIV-US.
Develop and implement processes for supplier quality, and trending for improvements.
Responsible for management and maintenance of the BIV-US supplier database.
Drive Quality and Compliance improvement initiatives throughout BIV-US based on opportunities for improvement highlighted during audits and Quality Management Reviews.
Assemble and provide KPIs and metrics on supplier audit completions and transparency for corporate dashboard by required timelines.
B.S. or higher in a scientific discipline with a minimum of five (5) years’ experience in the pharmaceutical and/or biological industry, or appropriate combination thereof, and a minimum of 2 years prior leadership experience.
Broad knowledge of GMPs with awareness of other compliance areas (e.g., GLPs)
More than six (6) years’ experience leading employees and projects is required.
A minimum of 3 years prior experience leading internal GMP audits and/or leading GMP vendor / supplier audits.
Recognizes the significance of results and observations from a regulatory or compliance point of view, and from commercial and technical perspectives.
Participates in setting compliance or regulatory objectives and policies.
Thorough knowledge of the processes used within the group, thorough understanding of site procedures, and ability to suggest/make improvements in processes. Extensive training, education, or experience directly applicable to job responsibility strengthened by understanding of quality concepts and/or technical processes related to job responsibility.
Capable of making complex decisions that may involve policy interpretation. Decisions routinely impact other departments, business units, customers or vendors. Appropriately balances risk when making decisions.
Independently develops solutions to problems of wider scope, using established methods. Proactively searches for solutions to problems through collaboration.
Independently plans, conducts and interprets work on complex and/or multiple projects under general direction. Can manage portions of assigned projects.
Ability to evaluate and interpret data and formulate logical and sound conclusions and recommendations.
Attention to detail and commitment to customer service.
Scientific and analytical thinking.
Excellent written and verbal communication skills.
Knowledgeable in statistical analysis.
Proficient in computer software and programs associated with the area.
Ability to lead cross-functional teams for quality initiatives.
Good understanding of domestic and international pharmaceutical and biological regulations (e.g., FDA, USDA, EU, etc.).
Effective change agent.
Ability to effectively manage people.
Effective interpersonal skills with a diverse group of individuals at all levels within the organization.
Excellent organizational skills with demonstrated ability to multi-task.
Desired Experience, Skills and Abilities\:
Must have a minimum of three (3) years’ experience leading internal GMP audits and/or leading GMP vendor / supplier audits.
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.
Ingelheim is firmly committed to ensuring a safe, healthy, productive and
efficient work environment for our employees, partners and customers. As
of that commitment, Boehringer Ingelheim conducts pre-employment verifications
and drug screenings. *LI-BR1