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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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees.
The Manager, QA Release will provide technical direction and supervision in the QA Release department according to company policies and corporate business plans and provide technical competence through proper selection and training the work force. This role ensures QA Release functions are performed according to current regulatory requirements and company policies. The incumbent is 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 deputy/alternate deputy during their absence is the Principal Specialist/SR Specialist, QA Release.
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. Ensures 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. Ensures adherence to procedures and validation requirements. Performs documentation review of media fills and media fill protocol approvals as needed. Ensures media fill status is continuously tracked and communicated to assure products impacted are released as soon as satisfactory completion is confirmed.
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.
Requirements
Bachelor's degree in a relevant scientific discipline plus ten (10) years of relevant experience. OR MS degree in a relevant scientific discipline plus eight (8) years relevant experience. OR PhD in a relevant scientific discipline plus five (5) years relevant experience is required for this position. NOTE: Relevant BIAH experience may be weighted more significantly.
Core Competencies
Business/Technical Knowledge, Communication, Delivering Results, Innovation & Change, Lives Lead & Learn, Quality Orientation/BPE, Teamwork/Collaboration, Knowledge of Regulatory Requirements/Compliance. Problem Solving/Resolution and Customer Advocacy/Personal initiative.
Management Competencies
Growing talent Leveraging Strategic Relationships Managing performance External focus
Quality Competencies
Analytical Thinking Project/Program Management - leading, demonstrating, and influencing Planning and Organization.
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.
Desired Skills, Experience and Abilities
Additional Duties & Responsibilities
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 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 GMPs, 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. Generates information/data for possible market actions. Reviews and performs approvals for reprocessing activities for non-conforming serials and within regulatory requirements. Serves as market recall coordinator in the event of market actions. 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.
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