Sr. QA Manager, Computer System Validation

Compensation Data

This position offers a base salary typically between $115,000 and $181,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits, please click here. 

Description

Purpose of this position is the responsibility to ensure that BI's global, cross-business and cross-functional computerized systems in scope meet the requirements of applicable global regulatory agencies.
The role has to approve that such systems are implemented according to current regulatory requirements and maintained in such a manner to ensure an ongoing state of quality and control.

Contribute to design appropriate local, regional and global organizational structures and processes with broader impact supporting the IT application and template landscape.

Takes active advises on setting up optimal validation strategies and ensures that all process and technical topics are fully considered
Responsible for quality oversight of the entire application system elements in scope, during its implementation and operational phase, including KPIs and trend analysis. Recognition and derivation of necessary control measures including necessary escalations.

Management of internal and external resources required to ensure quality of implementation and maintenance of computerized systems in scope.

 

• This role is based on-site at our Ridgefield, CT location with hybrid flexibility of 2-3 days per week on-site. 

Duties & Responsibilities

1. Global Quality responsibility for ensuring computerized systems used within area of responsibility are implemented and maintained in such a way to meet all global regulatory requirements, including computerized systems validation, GxP regulations (regarding processes which are supported by the computer system), electronic records and signature requirements. 
Ensure the right level of Risk taking within the Risk Based Approach depending on process and technical risks
Proactive and consultative engagement of the Computer System Validation role within agile projects

2. Guide business stakeholders and cross-functional project teams through the LeVa framework by conducting self-developed, process adapted training. 
Give active feedback into the Computer System Validation (CSV, Management System Owner (MSO) Network on topics where the LeVa Framework can be optimized, especially on validation issues for new technologies. Provide expert input to stakeholders aimed at avoiding non-compliance risks that can adversely impact the business.
Development of solutions and presentation of new validation challenges (e.g. cloud computing, mobile apps, internet of things, artificial intelligence, big data) in cooperation with the International CSV Working Group, taking into account external regulatory requirements and best practice exchange with other companies

3. Contribute on strategic topics as requested by the manager. Define proactively and oversee validation concepts to be ready for the challenges of the dynamically changing technology environment (e.g. cloud computing, mobile apps, agile software development,)Development and alignment of concepts and assessment of selected topics with potential broader impact.

Contribute with ideas to cost and effort reduction balancing risk to cross-organizational and specialist topics .

4. Foster a common quality culture and understanding within the team and the corresponding business partners. Comply with the relevant (BI internal) safety guidelines and specifications in the working environment. Strive and support zero accidents. Perform safety measures according to internal requirements.

5. In the event of regulatory or internal audit interactions, represent Boehringer Ingelheim in regard to all inquiries pertaining to its area of responsibility relevant to the validation of computerized systems and processes supported by the computerized system in scope. Oversight on definition and implementation of Corrective Action Preventive Action (CAPA)as a result of inspections.

6. Perform self inspections to ensure compliance with internal and external regulations Ensures continuously improvement of the process and procedures in regards to computerized system validation in scope.
Reviews and approves relevant SOPs

7. Ensure that externals working/supporting the CSV team are adhering  to the agreed methodology. Provide guidance, defines work packages and monitors the defined deliverables.

Requirements

• Diploma degree and/or Masters degree (e.g. MBA, MSc) and/or Ba