Submission for the position: Associate Director, Quality Assurance - (Job Number: 231044)
https://tas-boehringer.taleo.net/careersection/jobdetail.ftl?job=231044&lang=en
Associate Director, Quality Assurance
Description:
The Associate Director, Quality Assurance is responsible for ensuring compliance of site manufacturing processes according to cGMP regulations.  Also responsible for implementing, maintaining, and monitoring all Quality processes necessary for that assurance. This includes leading skilled people, running the operations according to cGMP regulations, and identifying and implementing business process improvements and that will drive business performance and Quality innovation. Incumbent provides technical expertise on Quality standards and processes to team members; provides strategic direction on specific departmental operations and implements tactical planning within the department for daily operations. Responsible for major organizational Quality function such as Deviations, Quality Agreements, Validation Oversight or Change Controls.
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:
• Plans, directs and manages the work of assigned Quality group(s); provides technical leadership to corrective and preventive action (CAPA), deviation and change controls as necessary to ensure each project within the group is completed in accordance with departmental mission. Establishes department mission statements.
• Provides oversight for the development of project budgets and monitors expenditures. Optimizes allocated department resources. Works with clients, suppliers, contracted organizations and other BI sites as necessary to achieve goals.
• Proposes and executes process and procedural changes to improve process performance, robustness, productivity and efficiency. Applies metrics to departmental mission to drive continuous improvement.
• Collaborates functionally and cross-functionally to implement Quality strategy and objectives. Performs both independently and in team settings. Works closely with department Director to set and implement goals.
• Serves as Leader for new initiatives relating to department. Removes barriers to successful implementation and works to resolve them.
Requirements:
• Bachelor's degree from an accredited institution, preferably in Life Sciences, Engineering or similar pursuit, required.
• 8 years of experience working in the Quality aspects of life sciences or closely related industry, required.
• 5 years of management and/or leadership experience, including experience managing within complex matrix organizations and projects, required.
• Must have demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• Requires strong collaboration, negotiation and ability to in a team environment and collaborate with peers.
• Overall understanding of Quality Systems and processes within a pharmaceutical / biopharmaceutical manufacturing organization
• Prior experience budgeting and financial forecasting highly desired.
• Must have demonstrated abilities in goal setting, team leadership, staff coaching and development and communication.
• Strong understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating.
• Physical Demands / Surroundings – Works primarily in an office setting under desirable conditions with few or no disagreeable features.  Duties do not require incumbent to exert physical effort beyond normal office conditions.  The individual may be required to enter and perform work in the manufacturing areas.  This may include periods of frequent standing or working.  Some domestic and international travel required.
• Visual Demands - Must be able to read and see clearly.  Vision clarity with or without correction to read handwritten as well as computer generated documents.
• Attendance / Schedule - Attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager.
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
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.
Quality/Compliance
Americas-US-GA-Athens
US-Boehringer Ingelheim Animal Health
Schedule: Full-time Location(s): Americas-US-GA-Athens