Associate Director, QC Compliance - QA for QC (On-Site in College Station, TX)

FUJIFILM Diosynth Biotechnologies; United States; On-site; USD 108,000 - 129,000; Full time

Job summary

A leading biotechnology company is seeking an Associate Director of QC Compliance to oversee quality control processes and ensure adherence to regulatory standards. This pivotal role involves managing QC SOPs, training, and compliance efforts while leading a team in a collaborative environment.

Qualifications

• 8+ years of experience in Quality Control/Quality Assurance in the pharmaceutical industry.
• 5 years of leadership experience required.

Responsibilities

• Lead efforts to ensure QC processes comply with quality systems and GMP regulations.
• Manage and mentor a team of QC Compliance professionals.

Skills

Leadership

Problem Solving

Communication

Analytical Skills

Education

Bachelor’s degree in Chemistry, Biology, or other scientific discipline

Advanced degree

Job description

Associate Director, QC Compliance - QA for QC (On-Site in College Station, TX)

Associate Director, QC Compliance - QA for QC (On-Site in College Station, TX)

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***This is an on-site position in College Station, TX.

The Associate Director of Quality Control Compliance is a pivotal role within the Quality Control department, responsible for ensuring adherence to quality systems and regulatory standards. This position is dedicated to overseeing key QC processes, including the lifecycle management of QC SOPs, training curricula, change control, deviation management, and data integrity. This leader will drive compliance within the Quality Control function.

Reports to Head of Quality Control

Work Location College Station, TX

Primary Responsibilities:

Compliance with Quality Systems:

• Lead efforts to ensure that Quality Control processes are in full compliance with established quality systems and GMP regulations.
• Collaborate with the Quality Assurance team to align QC practices with overarching quality standards without duplicating roles in QA.

Quality Standards and Process Management:

• Oversee the lifecycle management of Quality Control Standard Operating Procedures (SOPs), ensuring they meet quality requirements and are consistently followed.
• Develop and maintain effective training programs to enhance QC staff competence in compliance with quality systems.

Training Coordination and Effectiveness:

• Organize and oversee training activities, ensuring all QC personnel are knowledgeable and proficient in QC procedures and regulations.
• Evaluate the effectiveness of training programs, making adjustments to optimize learning outcomes and compliance adherence.

Change Control Management:

• Manage change control activities related to QC methods, equipment, and processes to maintain continuous compliance.
• Ensure thorough documentation and implementation of changes to uphold product quality and regulatory standards.

Leadership:

• Manage and mentor a team of QC Compliance professionals, fostering a positive and collaborative work environment.

Deviation Management and Trending:

• Lead deviation investigations within QC, ensuring robust root cause analysis (RCA) and application of corrective and preventive actions (CAPA).
• Conduct trend analysis on deviations to identify areas for process improvement and enhance compliance.

GMP Documentation and Data Integrity:

• Ensure meticulous compliance with Good Documentation Practices (GDP) and data integrity throughout QC operations.
• Conduct holistic reviews of testing, batch records, and stability studies to identify trends and rectify discrepancies.

Data Trending and Analysis:

• Direct data trending and analysis efforts to provide valuable insights into QC performance, helping drive improvements in quality and stability.
• Collaborate with QC teams to implement data-backed improvements that support compliance and quality enhancement.
• All other duties as assigned.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or other scientific discipline and 8+ years of experience in Quality Control/Quality Assurance within the pharmaceutical/biopharmaceutical industry, focused on compliance and quality systems.
• 5 years of leadership experience required.
• Experience with data integrity and compliance as related to quality control labs preferred.
• Advanced degree preferred.
• Strong understanding of GMP regulations and QC process management.
• Demonstrated leadership abilities.
• Demonstrated expertise in deviation management, RCA, CAPA, change control, and data integrity.
• Strong leadership skills with excellent project management capabilities.
• Highly analytical with strong problem-solving skills and a focus on compliance.
• Excellent communication and interpersonal skills to work effectively across departments.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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