Leads and Manages the Environmental Monitoring and Bacteriology laboratory personnel and equipment. Responsible for the oversight of testing and reporting accurate results. Ensures compliance with performance of analytical methods, training, document integrity, equipment upkeep and maintenance. Leads and delivers AAI through managing assigned department and modeling company best practices and expectations. Manages and drives GXP training, and administration of key QA systems such as CAPA, deviations, complaint, validation reviews, change control, controlled documents such as SOPs, Bench Records, etc. Responsible for implementing procedures to ensure global compliance with EU, USDA, and corporate requirements. Responsible for participating in audits and inspections, assisting with inspection readiness activities, assisting with the inspection team during regulatory agency inspections, and interacting with inspectors.
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:
Responsible for overall management of the reporting QC sections. Ensures compliance through the institution and oversight of training practices, methods for good documentation, Departmental procedures for testing and analysis, GXP's, Regualtory commitments and requirements, Cooperate procedures/polices and safety procedures.
Identify and resolve real or potential quality issues; develop and maintain KPIs, metrics and monthly report for Quality; identify and implement continuous process improvement initiatives.
Ensure all reporting employees are trained in applicable regulatory requirements, analytical methods, company procedures, and relevant systems.
Implement work processes that mitigate errors. Institute best practices for review of analytical testing and results in order to mitigate errors in result reporting or retests. Trend performance and develop indicators for test reporting oversight.
Lead and/or participate in special projects or duties as assigned and ensure department and individual priorities are aligned with corporate, operational and functional priorities. Ensures that policies, SOPs, and safety procedures are instituted and followed.
Manage expense and capital department budget within established parameters Responsible for Interprets requirements for compliance and creates, develops, and implements Departmental procedures that drive the business needs. Initiates review and revision of testing procedures and specifications that improve the business through put and manpower.
Recognizes the significance of testing results and observations from a regulatory or compliance point of view, and from commercial and technical perspectives. Sufficient knowledge to assist, when needed, other parts of the company in evaluating compliance issues.
Formulates compliance or regulatory objectives and policies.
Applies analytical/risk management skills to make complex operational decisions. When needed, can be relied upon to make sound decisions related to policies. Decisions routinely impact other departments, business units, customers or vendors. Appropriately balances risk when making decisions.
Independently plans, conducts and interprets work on multiple complex projects with little or no direction. Oversees major portions of assigned projects, providing technical and project leadership. Establishes and leads project teams or committees, develops charters and objectives.
Consulted by members of other departments for expertise and direction on Quality Systems. In-depth knowledge of all quality compliance areas.
Develops solutions to problems which are creative, thorough and practical, giving full consideration to impact to the business.
Responsible for ensuring compliance to Outlines of Production, Dossiers, Code of Federal Regulations, EMA, Country specific guidances, Site and Corporate Procedures and guidelines.
Bachelor's degree in microbiology or similar scientific field from an accredited institution.
In addition to Bachelor's degree:
A minimum of ten (10) years of experience in analytical laboratory or production environment
A minimum of five (5) years of experience in Quality Control in a regulated industry
A minimum of five (5) years of leadership experience.
Knowledge of biological/pharmaceutical manufacturing processes and operations
Well versed in all regulatory requirements, inclusive of cGMP, USDA and EU regulations and BIAH requirements. Must demonstrate mastery of at least one compliance area (GLP, GMP, etc.).
Ability to effectively manage a substantial number of people and lead cross-functional teams related to quality initiatives
Ability to evaluate and interpret data and formulate logical and sound conclusions and recommendations, using technical knowledge to solve problems
Attention to detail and commitment to customer service
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 departmental/site objectives. Demonstrated mastery of quality concepts and technical processes related to job responsibility.
Excellent reading/writing and communication skills.
Well versed in statistical analysis.
Proficient in computer software and programs associated with the area.
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 innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
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. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.