Site Quality Operations Head

Key Responsibilities

• Supervisory Responsibilities: Interview, hire, train, and manage teams.
• Compliance: Ensure adherence to cGMP, GDP, SOPs, Work Orders/Instructions, DSCSA, PDMA, and other relevant policies, procedures, and regulations.
• Quality Operations: Represent the facility as the Quality Leader for hosting and facilitating audits, supporting non-conformance identification and resolution, and leading continuous process improvement initiatives.
• Auditing: Conduct in-process checks/audits for Operations on the shopfloor and support the assessment of CAPA effectiveness.
• Training and Development: Perform on-job training and interpret QA procedures for employees.
• Client and Stakeholder Management Support: Support Compliance and Quality Assurance stakeholders in establishing TQA/QAg, aligning with SLAs, and providing consultative services on changes to shop floor operations.
• Continuous Improvement: Lead continuous improvement initiatives and support implementations that enhance functionality and performance.
• Communication: Present recommendations, address issues, and collaborate with various departments.

Minimum Job Requirements

• Bachelor's degree in engineering, life sciences, or related disciplines; or ten (ten) or more years related experience and/or training; or equivalent combination of education and experience required.
• Four (4) or more years of relevant experience in GxP, leadership position, and/or demonstrated a high leadership potential in a Biotech/Pharmaceutical/Medical Device industry, preferably in supply chain and third-party logistics.

Knowledge, Skills & Abilities

• Expertise in internal audits and strengthening controls for external audit readiness.
• Analytical: Analyzes complex information, research data, designs workflows, and demonstrates attention to detail.
• Managing People: Leads teams effectively, provides feedback, develops talent, and drives continuous improvement.
• Oral Communication: Communicates clearly, listens actively, responds effectively, and presents well in groups.
• Problem Solving: Identifies issues, analyzes information, develops solutions, and exercises sound judgment.
• Project Management: Plans, coordinates, tracks progress, and delivers projects on time and within budget.
• Technical Skills: Builds expertise, pursues development, and shares knowledge with others.
• Written Communication: Writes clearly, edits effectively, and interprets written and numerical information.
• Change Management: Plans and communicates change, builds commitment, and supports effective transitions.
• Knowledge of Company Policies: Knowledge of company policies, regulations, and cross-functional business interactions.
• Knowledge of Product-Related Regulations: Strong knowledge of applicable federal regulations and compliance principles.
• Knowledge of Safety Practices: Knowledge of product-related regulations and safety practices.

Physical Demands

• Ability to stand and walk for extended periods during inspections and operational support.
• Ability to bend, stoop, reach, and move throughout operational areas.
• Ability to lift up to 25 pounds regularly and up to 40 pounds occasionally, with or without reasonable accommodation.
• Ability to use hands and fingers for document handling, computer use, and detailed inspections.
• Ability to visually inspect materials, labels, and documentation with close attention to detail.
• Ability to work in warehouse or manufacturing environments with varying temperatures, noise, and moving equipment.
• Ability to sit for extended periods while reviewing records and completing documentation.

Pay Range

The expected pay range for this position is $100K - $130K annually. The actual compensation for the position may vary based on market differences and on factors such as skills, experience, qualifications, and can vary based on location and/or work schedule.

Benefits

In addition to base pay, CareTria offers a comprehensive benefits package. Full-Time benefits include access to health, dental, and vision insurance; retirement plan options; paid time off; paid parental leave; employee assistance programs; and other perks. Eligible employees may also have access to performance bonuses.

Caretia is an Equal Opportunity Employer.