Full-time
Description:
Description\:
This is an expert-level individual contributor role, responsible for maintaining quality systems at the site to achieve company goals and department objectives.
The Incumbent serves as the subject matter expert for various Quality Systems and processes (For example, Quality management review, quality risk management, Deviation/CAPA, Change Control). This role independently exercises judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for resolving complex problems, where analysis of situations or data requires in-depth evaluation of various factors, and considerable judgment in resolving problems and making routine recommendations.
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 several 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\:
Quality process improvement and implementation\:
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• Supports established quality systems according to corporate procedures.
• Serves as a quality system expert and engages with the site and Quality Systems Manager to uncover issues and concerns relating to quality systems and facilitates resolution and continuous improvement.
• Manages export documentation program for the site including approval of certificates for product distribution.
Key Performance Indicator monitoring\:
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• Monitors key quality indicators and collects quality data for the site and various Quality dashboards.
• Shares learnings and improvements across functional group and the business including the on-going training of junior team members.
Training\:
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• Trains employees on Deviation/CAPA and Change Control systems. Grants system access to employees as appropriate.
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• As applicable, serves as the Team Lead (project manager) during planning and implementation of improvement projects relating to quality systems; provides communication of issues, project updates and changes to site management, stakeholders, and users.
• Develops training materials to ensure high level of quality and consistency for deviations/CAPAs and change controls.
• Serves as the lead and primary contact for product registration activities for the site and works with Regulatory Affairs groups globally to ensure successful product registration and renewal activities.
• Leads alignment of release functions across different areas within production (Central Services, Cells / Media Production, Active Ingredient Production, Formulation / Filling / Freeze Drying / Capping Production, and Quality Control Testing).
Requirements\:
• Bachelor's Degree from an accredited institution with five-plus (5+) years of related professional experience in Quality Assurance, Quality Control, Sterility Assurance, Engineering, Production, or Qualification / Validation in a regulated industry.
• Experience in deviation investigations and change control and supporting computer-based systems/ applications.
• Project management experience is a plus.
• Organizational skills, and ability to manage tasks based on experience leading projects.
• Ability to communicate clearly and professionally, both verbally and in writing.
• Well-developed interpersonal skills, with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
• Solid knowledge of Good Manufacturing Practice and international regulations.
• Ability to independently make sound decisions and manage priorities in alignment with department and site drivers.
• Ability to interpret and relate quality standards for implementation and review to functional areas.
• Flexibility in problem-solving, providing risk-based options towards challenges for management review and decision making.
• Development and delivery of individual and department goals, delivery of site and divisional goals requires a high level of creativity and innovation as well as technical knowledge and organization.
• High level of network interaction with other sites, functions, and Corporate.
• Contributes to the completion of cross organizational projects and goals.
KEY COMPENTENCIES REQUIRED\:
• Advanced scientific and analytical thinking.
• Excellent written and verbal communication skills.
• Proficient in computer software and programs associated with the area.
• Ability to participate on cross-functional teams for quality initiatives.
• Working knowledge of domestic and international pharmaceutical and biological regulations (e.g., FDA, USDA, EU, etc.).
• Effective interpersonal skills with a diverse group of individuals at all levels within the organization.
• Good organizational skills with ability to multi-task.
• Attention to detail and commitment to customer service.
Eligibility Requirements\:
• 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.
• This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
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.
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