Manager, Site Quality Head (2026-8006)

Caretria•Lakewood, NJ

20d•$100,000 - $130,000•Hybrid

About The Position

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.

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.
Expertise in internal audits and strengthening controls for external audit readiness.
Analytical skills: Analyzes complex information, researches data, designs workflows, and demonstrates attention to detail.
Managing People skills: Leads teams effectively, provides feedback, develops talent, and drives continuous improvement.
Oral Communication skills: Communicates clearly, listens actively, responds effectively, and presents well in groups.
Problem Solving skills: Identifies issues, analyzes information, develops solutions, and exercises sound judgment.
Project Management skills: 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 skills: Writes clearly, edits effectively, and interprets written and numerical information.
Change Management skills: 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.

Responsibilities

Supervise teams located at the facility(ies), including interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, and addressing complaints and problem solving.
Ensure adherence to cGMP, GDP, SOPs, Work Orders/Instructions, DSCSA, PDMA, and other relevant policies, procedures, and regulations.
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.
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).
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.
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.
Manage performance of Operations and Quality Operations employees for on-job training and interpretation of QA procedures and other critical needs as required.
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.
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).
Communicate effectively through 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.