The Site Quality Head will oversee the Quality Operations function for the Site(s), ensuring operations are conducted in compliance with Good Manufacturing Practices, Good Documentation Practices (GxP), Standard Operating Procedures, and other relevant policies, procedures, and regulations. This role involves managing the Quality Operations teams responsible for the shop floor activities, hosting Client and Regulatory Audits of the facility(ies), conducting in-process checks/audits, leading cross-functional process improvement initiatives, and working closely with Compliance/Quality Assurance, key stakeholders, and clients to maintain high-quality standards. Role is expected to be on-site at least 4 days per work week and physically present at facility during any Audit.
This position includes multiple levels, with leadership scope and complexity of work increasing based on demonstrated skills, experience, and sustained performance.
KEY RESPONSIBILITIES:
Supervisory Responsibilities: This job has supervisory responsibilities of teams located at the facility(ies). Carries out supervisory responsibilities in accordance with the organization's policies, as well as applicable to federal and state laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and problem solving.
Compliance: Ensure adherence to cGMP, GDP, SOPs, Work Orders/Instructions, DSCSA, PDMA, and other relevant policies, procedures, and regulations.
Quality Operations: Represent the facility(ies) as the Quality Leader responsible for hosting and facilitating all Client/Regulatory audits/inspections, supporting non-conformance identification and resolution, continuous process improvement and operational excellence initiatives, as well as CAPA development and implementation.
Documentation and Reporting: Review and approve critical quality communications, investigation summaries, non-conformances/deviations, Client-specific Operational Work Instructions, and other quality-related documents. Support Quality Assurance and Compliance in the Risk Assessment and Mitigation activities for the facility(ies).
Cross-functional Collaboration: Lead cross-functional teams and collaborate with subject matter experts for continuous process improvement, CAPA implementation, new business implementations, and when required client-specific requests.
Auditing: Represent the facility(ies) as the Quality Leader responsible for hosting and facilitating all Client/Regulatory audits/inspections. Conduct in-process checks/audits for Operations on the shop-floor, support the assessment of CAPA effectiveness checks.
Training and Development: Performance management of Operations and Quality Operations employees for on-job training and interpretation of QA procedures and other critical needs as required.
Client and Stakeholder Management Support: Support Compliance and Quality Assurance stakeholders in the establishment of technical quality agreements (TQA / QAg), alignment with SLAs and client expectations, and provide consultative services on impact of changes to shop floor operations including developing mitigation action plans.
Continuous Improvement: Lead continuous improvement initiatives focused on building quality into the everyday operation without negatively impacting throughput. Work to improve overall quality performance by eliminating waste while maintaining quality. Support implementations that enhance functionality and performance at the facility(ies).
Communication: Strong written and oral communication skills for presenting recommendations, addressing issues, and collaborating with various departments and represent the Facility(ies) in above site meetings/strategic discussions.
The above duties are meant to be representative of the position and not all-inclusive.
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.
4+ 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, researches 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.
Strong knowledge of company policies, regulations, and cross-functional business interactions.
Strong knowledge of applicable federal regulations and compliance principles.
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.
Expected to be on-site at least 4 days per/week and physically present at facility during any Audits.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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. 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.
CareTria is an Equal Opportunity Employer