Manager, QA Release; Formulation and Filling

Manager, QA Release

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 Ingelheim's 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.

• 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.
• Demonstrates understanding of all immediate actions when critical issues that may impact product quality are found.
• Ensures quality notification process, regulatory field alerts, and proper assessment of impacted serials/products or processes is performed in a timely manner to assure affected product is properly quarantined and communicated.

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.

• 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…