(Archived) Group Leader, QA Release

Description: The basic purpose of this position is to provide technical direction and supervision in the QA Release department according to company policies and corporate business plans, to provide technical competence through proper selection and training the work force, assure QA Release functions are performed according to current regulatory requirements and company policies, responsible and accountable for release of products intended for the US, Non-EU and EU markets, and maintains area of responsibility within budget guidelines. The responsible deputies for this position in his/her absence is the Group Leader/QA Release and alternate deputy is AD, Quality Compliance (MES). This position also handles emergency and critical tasks within the QA Release team. 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: Manages the overall operation of the department. Prioritizes work, manages resources/staffing within areas of responsibility, provide training, resolves issues, develops and institutes quality and efficiency improvements, conducts performance reviews. Sets annual budget/spending and manages expenses within department. Communicates staffing expectations to QA management. Audits/Inspections: Participates in internal audits as assigned by management to include audit preparation, development of agendas, leads tours, provides documentation and responses for auditor requests Participates in 3rd party audits as assigned by management. Serves as a "co-lead" for audits/inspections. Serves as an SME for strategy rooms during internal and external audits/inspections. Provides audit responses to findings in area of responsibility or other areas as needed. Identifies, creates CAPAs and tracks them through to completion. Documentation Review/Approvals: Resolves critical/major issues that are not defined by SOP and that may have impact to regulatory filings/product quality and provides direction as needed through Quality systems knowledge and cGMPs. Quality notification process, regulatory field alerts, and proper assessment of impacted serials/products or processes is performed to assure affected product is properly quarantined and communicated. Performs review and approvals of MBPS/CBRs/international permits for international releases. Holds quality and reliability as high standards of production and service for own work. Follows established quality assurance procedures and understands how factors outside of own work area impact processes and tasks within own work area. SAP: Performs conditional usage approvals as needed and are reviewed to properly assess risk prior to usage of the item in production. Serves as a key user for SAP in the resolution of system or set up issues. Resolves SAP issues in a timely manner. Issues tickets as directed in local and corporate procedures for items beyond their control. Performs assessment and approvals of requests for items that are returned to stock. Training: Completes all assigned training by target due dates as assigned. Develops training plans and trains others, including training outside of area of responsibility. Develops and maintains training curricula within areas of responsibility. Change Control: Performs review and approvals of change controls as a subject matter expert (SME)in QA Release for routine change controls. Performs review and approvals of significant change controls (new facility/new equipment/new product). Performs review and approvals of emergency change controls (non-routine items)having direct product impact. Completes change control action items as assigned. Revises existing procedures as changes occur. Creates new documents (SOPs/Forms/templates) as needed. Deviations/CAPA: Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review. Assesses, reviews and approves deviations (dept approver) and assigns investigations as needed. Performs immediate impact assessment of deviations to determine whether or not field alerts are warranted. Writes or participates in deviation investigations for determination of appropriate root causes. Serves as QA approver for investigations as needed. Performs follow-up on CAPAs for completion for self as well as direct reports. Ensures CAPA extensions are requested prior to due dates as needed. Regulatory: Demonstrates understanding of regulations for various countries. Assesses product, procedures, recommends improvements and makes correct decisions based on GMP's, 9 CFR, Outlines of Production, compliance requirements. Routinely reviews regulatory correspondence/audit reports and assures compliance of QA Release procedures. Provides input into regulatory filings (OOPs/dossiers). Provides approvals for non-routine testing/samples Reviews and performs approvals for reprocessing activities for non-conforming serials and within regulatory requirements. Actively participates in external groups (PTEA, AHI). Routinely attends meetings for new regulatory requirements and industry opinions. Asks questions for understanding and provides meeting minutes to BIAH departments as needed. Attends external training/courses on regulatory compliance to learn existing and/or new regulatory requirements (IICAB, etc.) Serves as a subject matter expert for possible regulatory updates/changes. Provides direction and communication to affected departments as regulatory updates/changes occur. Requirements: Bachelor’s degree in a relevant scientific discipline plus 8 years relevant experience or MS degree in a relevant scientific discipline plus 6 years relevant experience or PhD in a relevant scientific discipline plus 3 years relevant experience is required for this position. Core Competencies: Business/Technical Knowledge, Customer advocacy & personal initiative, Communication, Innovation & Change, Lives Lead & Learn, Teamwork/Collaboration, , Problem Solving/Resolution - developing Delivering Results, Quality Orientation/BPE, Knowledge of Regulatory Requirements/Compliance - influencing. Management competencies: Growing talent - developing and demonstrating Leveraging Strategic Relationships - influencing Managing performance - demonstrating External focus - Influencing Quality Competencies: Analytical Thinking - influencing and demonstrating Project/Program Management – leading ,demonstrating, and influencing Planning and Organization - leading Skills: Exceptional logical skills with excellence in written and verbal communication skills. Excellence in comprehension/application of USDA and EU regulatory requirements for production and distribution of regulated biological articles. Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks. Ability to make decisions with minimal supervision regarding the acceptability of product based on documentation provided. Excellent attention to detail. Management of direct reports for adherence to company policies, resolution of conflict and annual personnel performance measurement. Excellent organizational and time management skills. Fosters a business environment that encourages continuous learning and rewards strong business and technical skills. 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.