Manager IT Product Software Quality

Job Description:

• Provides senior-level consultation and direction to functional areas (including Software Quality and DevOps teams) on IT Quality policy, process, and procedures supporting Product Software (SaMD/SiMD).  
• Identifies, proposes, and leads significant improvement programs related to IT Compliance policies, processes, and procedures in support of the BTS IT domains. Leads the IT Quality activities across multiple projects/client areas.
• Ensures that documentation complies with policy and procedure requirements in conjunction with internal and external business and technology partners.  
• Develops and leads the implementation of testing methodologies and/or IT Quality practices. Train and educate the appropriate business and IT communities on quality, compliance and standardize best practices for IT systems as appropriate.

Job Responsibilities:

• Ensures IT validation packages comply with applicable Corporate/Divisional Policies and procedures and regulatory requirements.
• Works autonomously with related IT contacts and the business process SMEs for this purpose.
• Supports Software Development teams as SQA lead for the automated testing and implementation of regulated IT applications.
• Ensures continuous improvement and gives input related to the validation strategy for IT changes.
• Coordinates the introduction of new strategic methodologies; supports and approves the overall validation of global regulated applications.
• Drives the GXP Inspection Support and defends the validation strategies to internal auditors, regulatory authorities, and other certified bodies
• Provides IT validation subject matter expertise
• Apply SQA Engineering principles throughout the Agile or Waterfall Software Life Cycle to identify defect and design flaws
• Collaborates with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensure business needs are being met.
• The role must be familiar with Quality Risk Management principles and practices and will guide teams and management with risk-based decision-making capabilities.
• Applies Good Documentation Practices and assists as appropriate with required documentation for compliance purposes.

Position Accountability/Scope:

• The role reports to the Senior Manager IT Quality and is within the IT Quality Operations function of BTS IT. The role works with the senior levels of the BTS IT organization as well as leaders across the Quality Organization to drive improvements in BTS SQA Operations.
• The role works closely with peers and lower levels of BTS IT to sustain a quality mindset within the IT organization.
• The position is accountable for all phases of the SLC activities and works directly with BTS IT, Divisional Quality, and relevant Process Owners.
• Provides quality guidance to less experienced staff.
• Acts as a mentor to lower-level individual contributors. 
• Decisions and actions have an impact on business success.
• Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays, audit findings, and considerable expenditure of resources.

Minimum Education:

• Bachelor’s Degree in Computer Science, Information Technology or equivalent plus 8+ years of related work experience with IT Quality in the life science industry, or an equivalent combination of education and work experience.
• Certifications from ASQ and ISO9001 or ISO13485 are preferred.

Experience Required:

• Strong knowledge of GXP regulations and software validation principles supporting Product Software.
• Expertise in 21 CFR Part 820 and 13485 regulations.
• Strong knowledge of risk management principles, regulatory requirements, and industry best practices.
• Experience with Agile, and/or Lean software development practices.
• Strong analytical skills and the ability to organize work in a logical and succinct manner.
• Highly self-motivated, goal orientated, and self-directed.
• Demonstrated ability to operate and innovate in a team with a fast‐paced environment, balancing both strategic and tactical needs.
• Familiarity with automated testing and implementation
• Familiarity with Pivotal Tracker, GitHub, JIRA, Selenium, Bitbucket, HP ALM, and/or other automation/continuous integration tools
• Flexibility to adapt to changing assignments and ability to effectively prioritize efforts
• Effective written and verbal communication (in English) to all levels of management.
• The role must maintain compliance expertise and be effective at applying requirements into the IT and business environment that supports business goals.