Quality & Compliance Engineer

No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.

We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.

Key Responsibilities:

- Drive the implementation of Operational Excellence and Continuous Improvement initiatives, focusing on measuring labor productivity, identifying opportunities for enhancement, and establishing relevant metrics and measurement systems
- Support Change Management efforts for key functional initiatives and Lean Transformation certification
- Oversee the maintenance of visual boards and measurement systems for effective daily management
- Manage departmental Business Performance metrics, providing regular reports and escalating issues as needed to senior leadership.
- Develop and manage risk mitigation strategies, Business Continuity Plans, and disaster recovery modules, including conducting risk management assessments and business impact analysis
- Identify and provide educational opportunities to the department on how digital solutions may impact team workflows, while supporting the integration of these changes
- Assess and review the department’s current digital capabilities and expertise levels
- Collaborate closely with departmental stakeholders to develop a digitalization strategy and key initiatives
- Work with stakeholders to understand operational processes, pinpoint inefficiencies, and partner in driving digital transformation efforts
- Define and implement digital initiatives to deliver the desired business outcomes
- Coordinate effectively within the project team and maintain strong collaboration with external functions
- Manage daily project activities and resources, while leading project management team meetings
- Continuously monitor project progress and provide regular status updates to key stakeholders
- Assist the department in preparing for site Inspection Readiness meetings and serve as the auditee for ASM internal audits
- Participate as a member of the F&E Triage team for all regulatory inspections, managing inspection requests, preparing responses, and advising Subject Matter Experts on response strategies
- Support inspection readiness and conduct pre-audit walkdowns to ensure F&E complies with required standards
- Track and support F&E Quality Management Review metrics, ensuring appropriate visual boards are maintained
- Lead deviation investigations for F&E with the collaboration of Functional Area Owners and other SMEs, and provide support for F&E deviation triages

**Requirements**:

- Master’s degree in Computer Science, Engineering, or a related field
- Bachelor’s degree with 2 years of directly related experience in a pharmaceutical manufacturing environment
- Associate degree with 6 years of directly related experience in a pharmaceutical manufacturing environment
- Familiarity with documentation in highly regulated settings
- Ability to work both independently and collaboratively
- Strong understanding of customer needs and quality requirements
- Excellent team player, capable of working effectively within and across teams
- Good planning and tracking skills, with the ability to use appropriate program management tools and manage multiple programs based on priorities
- Highly organized with the ability to manage timelines, deliverables, and resources effectively
- Strong interpersonal, verbal, and written communication skills, with the ability to simplify complex information
- Skilled in prioritizing and multitasking to enhance productivity and manage workload in a fast-paced, rapidly changing environment
- Demonstrates critical and creative thinking, problem-solving abilities, and clear, concise written and verbal communication
- Customer-oriented with a strong focus on meeting customer needs
- Knowledge and experience in operational excellence and project management
- Ability to tactfully negotiate and positively influence peers, with added advantages for knowledge and experience in digitalization