Boehringer Ingelheim Associate Manager, Quality Assurance, Quality Third Party (Gainesville) in GAINESVILLE, Georgia
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.
Quality Assurance representative for Raw Material Quality Third Party (QTP) Management for the Gainesville, GA Industrial Operations (IO) site.
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 oversight and coordination of Quality Third Party (QTP) management for raw materials, suppliers, subcontractors and service providers utilized at Gainesville, GA manufacturing site and in coordination with the Athens, GA manufacturing site. Position will require ability to make key independent decisions about QTP practices or activities stated below. Key areas of responsibility include the following:
Oversee, coordinate and lead raw material/third party teams to ensure consistent management of raw materials, suppliers, subcontractors and service providers and align with common practices for QTP management in coordination with the Athens, GA manufacturing site.
Determine common raw material practices including materials shared by the Gainesville site. Ensure alignment with applicable regulations, guidance, Directives, Quality Standards and local or Corporate Procedures. Mentor, train and coach other staff supporting QTP.
Organize cross functional team to annually conduct risk assessment of materials, suppliers, subcontractors and service providers to determine audit frequency.
Determine annual audit schedule based on assessment for routine, non-routine or for cause audits. Request audits in electronic database and tracks progress of annual audits.
Review existing audits conducted by supporting partners and determine if these audits are sufficient for the material or service provided or if additional audit is required.
Management of Raw Material Specifications:
Manage the review, development, and/or consolidation of specifications for raw materials with the goal of creating a master specification that can be used for the Athens, Gainesville, and Raleigh sites.
Identify raw materials that require a specification to be developed.
Prioritize specification development by risk/criticality.
Maintain alignment between specifications and raw material database.
Manage changes through local change control systems, controlled quality documentation, supplier notification/agreement and other processes as needed.
Management of Quality Agreements:
- Develop and manage Quality Agreements for raw material suppliers, subcontractors and service providers. Review/update existing quality agreements and establish new agreements with suppliers, subcontractors, and service providers with support from Boehringer Ingelheim site personnel. Maintain Quality Agreements in the electronic database. May require research and interaction with other sites or affiliates to negotiate and secure common Quality Agreements between multiple sites or issue an addendum to existing Quality Agreements. Will require interaction with vendors, subcontractors, service providers and internal Procurement and Legal teams to secure these agreements. Position will in some cases determine if existing Material Service Agreements (MSA) or other contracts could suffice as a quality agreement.
Management of Raw Material Questionnaires:
Manage applicable raw material questionnaires with suppliers, analyze and select the appropriate questionnaire and maintain information in the electronic database.
Determine applicability of various questionnaires for each vendor or supplier.
Schedule and manage reissuance of questionnaires at established intervals.
Achieve/maintain auditor qualification and conduct supplier, subcontractor and service provider audits as needed, or seek assistance from other qualified auditors across Boehringer Ingelheim or Boehringer Ingelheim to perform required audits.
Maintain supplier, subcontractor and service provider audit status list.
Represent QA in third party Supplier Corrective Action Request (SCAR) process. Attend quarterly third party business meetings as applicable and inform sites of relevant changes or facts.
Submit Rapid Quality Notifications (RQN) for raw materials as needed to QTP Management. Assess and respond to quality alerts for raw materials and determine if each risk is applicable to either site as notices are issued by QTP Management.
Participate in Strategic Raw Material meetings and informs the committee of any known critical raw material issues.
Work with Procurement to ensure all applicable directives and site procedures are applied. Ensure applicable confidentiality agreements are in place.
Obtain quality documentation from third parties as required.
Contribute to the development of a raw material identity program.
Bachelor’s Degree in Life Sciences Related Field
Minimum of 2 years’ previous experience in Quality Assurance for animal, human biologics or pharmaceutical manufacturing environment.
5-7 years’ experience in chemistry related field
Minimum of 3 - 5 years Auditor experience required and qualified auditor status preferred
Requires manufacturing production knowledge for animal or human biological or pharmaceutical industry
Desired Skills, Experience and Abilities:
Excellent verbal and written communication skills
Requires manufacturing production knowledge and knowledge of current GMPs and USDA regulations (9CFR) as well as knowledge of and/or experience working in a regulated environment (e.g. USDA, FDA, etc.)
Requires good knowledge of common QA concepts/practices.
Proficient with Microsoft Suite Applications and various technical business applications such as Oracle and SAP.
Must have strong leadership, team building and negotiation skills, ability and willingness to assist and lead teams as needed.
Superior organizational and time management skills, capability to train others and multi- task.
Must have ability to make sound independent fact-based decisions as well as assess the risk of those decisions. Must be flexible and able to work with little supervision.
Attention to details and accuracy is a must, as well as willingness to learn and apply new methods.
Ability to work cross-functionally and establish effective working relationships with other departments along with working independently, interacting with all levels of management as well as internal and external entities.
Must be able to travel at least 25% of the time.
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.
Organization: US-Merial, Inc.
Title: Associate Manager, Quality Assurance, Quality Third Party (Gainesville)
Location: Americas-United States-GA-Gainesville
Requisition ID: 174867