Job SummaryThe Systems Integration Senior Manager at Autoimmunity (AID) is responsible for planning and managing the systems integration team to succcessfully meet company goals and customer needs. In conjunction with the Autoimmunity Leadership team, this position is responsible for developing strategies to meet company goals and ensure the highest quality Autoimmunity products. Fosters collaboration across teams to facilitate technical integration; oversees cohesive development and delivery of systems products. Responsible for building and leading a high performing team, and ensuring compliance with all Quality System and other regulatory, company and administrative requirements.

Key Accountabilities

• With company leadership, defines department priorities, develops implementation strategies, defines scope and performs capability analysis with the support of technical resources; maintains project plans, budgets and timelines to ensure success.
• Manages creation of System level Customer and Product requirements; manages Systems projects by engaging with partners and stakeholders; leads verifcation and validation efforts.
• Responsible for Systems development lifecycle (roadmap), including, but not limited to, requirements analysis and trade-offs, system level risk management, transitions to manufacturing, obsolescence management and discontinuation support.
• Sets firm direction and strategy for functional area, maintains industry expertise to remain current on relevant technologies.
• Reviews Scope of Work (SOW) from vendors and engineering partners, ensuring scope is feasible and manages project timelines, budgets and deliverables from partners.
• Ensures close collaboration, communication, and problem solving with key internal and external stakeholders.
• Leads team through project planning activities, including conducting team planning sessions, setting expectations, communicating milestones and deliverables, clarifying dependencies, leading issue resolution, and ensuring escalation protocols are followed.
• Works with internal teams to perform root cause analyses to resolve issues to optimize results and ensure project execution and accountability.
• Supports Systems Integration efforts, operational planning, execution and evaluation of projects.
• Leads Systems Integration meetings and workgroup sessions.
• Leads organizational change management activities, including communication, training, implementation and post-implementation support, for issue resolution and product enhancement.
• Acts as the main point of contact for Autoimmunity Systems Integration activities.
• Keeps Systems Integration team trained, engaged and accountable to meet project milestones.
• Performs other duties and responsibilities as assigned.
• Ensures team compliance with all applicable Standard Operating Procedures (SOPs), Work Instructions, (WI), Standard Work (SW), Quality System Regulations (QSR), as well as Environmental Health & Safety (EHS), Human Resources and other requlatory and company policies.
• Acts as a role model by reflecting Werfen Values in quality of work and professional relationship.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• AID R&D Teams
• AID Quality, Regulatory, Compliance Teams
• AID Finance team
• AID staff based in remote locations
• External partners
• Other Werfen departments and staff

Minimum Education & Experience

Education

• Bachelor's degree in Bioengineering, Biomedical Engineering, Computer Science or related fields required; advanced degree preferred.

Experience:

• 10+ years working in progressively increasingly levels of management and leadership within the life sciences technology environment required.
• At least 8 years experience leading and developing management direct reports required.
• Provide track record of building and managing successful business oeprations and high performing teams required.
• Extensive experience leading and managing successful large scale technology projects related to product development and enhancement.
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities

• Deep knowledge of system development, implementation and integration projects.
• Methodical approach to crafting and testing systems (instruement, software and reagents).
• Excellent organizational and communication skills.
• Strong critical thinking and decision making skills.
• Excellent project management skills and ability to prioritize tasks; agility to adjust to changing priorities.
• Excellent ability to self-manage and prioritize project schedules, work effectively in a collaborative style with internal and external customers, team members, senior leadership and customers.
• Strong understanding of life sciences related compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO and other regulations and standards).
• Understanding of employment laws and experience monitoring compliance and prevention of employee relations issues.
• Understanding of standard finance and budgeting processes, including profit and loss, balance sheet and budget management.
• Interpersonal and emotional intelligence skills to develop and lead a high performing team.
• Advanced ability to constructively prevent and resolve conflicts.
• Strong influencing and negotiation skills, while building collaborative relationships and maintaining strong, positive working relationships.
• Strong ability to independently identify, asses and mitigate business risks.
• Strong ability to apply sound, systematic problem-solving methodologies and root cause investigation to identify, prioritize, communicate, and resolve quality issues.

Travel requirementsLimited travel requirement, may require occasional travel, including international.