Data and Risk Mgmt Sr QS Specialist

About the role

The Senior Quality Systems Specialist – Data Integrity and Risk Management plays a crucial role in ensuring patient safety and product safety, quality, and regulatory compliance. They are responsible for identifying, assessing, controlling, and mitigating risks throughout the product lifecycle.

Responsibilities

• Identifies, assesses, controls, and mitigates risks to ensure patient safety and product safety, quality, and regulatory compliance (e.g., ICH Q9).
• Supports the digitalization and automation of quality risk management data to drive data insights and process innovation.
• Documents business critical issues and risks following integrated risk-based decision making.
• Leads and conducts complex risk assessments under minimal supervision, leading and ensuring proper execution and utilization of appropriate risk models.
• Collaborates cross-functionally to determine and address data and reporting needs.

Requirements

• A minimum of a bachelor’s degree required (preferred: Data Integrity, Risk Management, Computer Science, Engineering Science or equivalent).
• Two or more years of experience mining and assessing data as a data analyst or similar role.
• Hands-on experience with executing various risk assessment methodologies, tools, and application of risk-based decision-making.
• Quality experience & applied knowledge of cGMPs including 21 CFR part 11 / Annex 11, ICH Q7 and Q9.
• A minimum of (2) years of experience in Quality Assurance within the pharmaceutical / medical device / life sciences and / or other GxP regulated industry.
• Experience using data analytics / visualization tools (e.g., Domo, Tableau, Looker, Qlik, Microsoft Power BI, Python) in data analysis; Solid understanding of data structures and transformations.
• Expert with Microsoft Excel or other business intelligence / analytical tools.

Qualifications

• Skilled in analytical and critical thinking used in problem solving techniques.
• Strong ability to prioritize assigned tasks in a high-paced environment and concurrently monitor tasks / assignments with other team members that may impact timely completion.
• Works effectively with people that have diverse work styles, talents, and ideas.
• Excellent communication skills.

Skills

• Analytical Reasoning
• Business Alignment
• Business Behavior
• Coaching
• Collaboration
• Communication
• Compliance Management
• Data Compilation
• Data Quality
• Data Savvy
• Document Management
• Problem Solving
• Quality Auditing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Services
• Quality Standards
• Systems Analysis
• Training People

Pay

The anticipated base pay range for this position is: $79,000.00 - $127,650.00

Benefits

• Consolidated Retirement Plan (pension)
• Savings Plan (401(k))
• Long-term incentive program
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year