Manager, Quality Control

About the role

This position is responsible for the daily QC oversight of PCI’s laboratory functions, including all operational and technical activities in delivering quality chemical, biopharmaceutical, and microbiologic testing services to our customers. The role oversees core activities such as in-process testing and microbiological testing, raw material testing, in-process testing, and reviewing release testing of GMP products. You will interact with clients on project-specific QC issues, approve department cGMP documents, contribute to cGMP reports, and manage QC staff to achieve these tasks.

Responsibilities

• Provide Quality Control oversight of all cGMP testing of raw materials, in-process, product release, clean utility, and environmental monitoring testing.
• Review and approve all QC-related investigations (deviations, OOS/OOT, EM investigations, etc.) both with internal and external laboratories.
• Maintain good relations and communications with clients as a primary technical interface.
• Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing personnel.
• Interface with supplier and customer quality representatives concerning problems with quality control and assure effective corrective action is implemented.
• Work with project teams to represent Quality Control, conduct risk assessments, and introduce best practices into QC processes.
• Lead customer interaction on all QC-related projects, including routine testing updates.
• Manage and develop professional and technical skills and performance of department members.
• Assure all QC functions and testing are performed according to FDA, EMA, ICH, and other international regulations as deemed necessary.
• Support regulatory information requests from customers as they pertain to QC.
• Support Operations, Project Management Staff, and Quality Assurance as needed.
• Drive technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance.
• Demonstrate substantial knowledge of subject matter, industry best practices, and trends.
• Perform other tasks as assigned by management.

Requirements

• BS in Chemistry, Biochemistry, Microbiology, Biology, or related life sciences field. Advanced degree preferred.
• 5+ years of experience in the Pharmaceutical or Biotechnology industry.
• Experience leading a commercial, aseptic drug product quality control team.
• 5+ years of previous QC management experience.
• Quality leadership experience working on cross-functional teams to harmonize operational, testing, and compliance processes.
• Experience managing 5+ people.

Skills

• Prior experience in a CMO or dealing with CMOs preferred.
• Excellent verbal, written, and interpersonal communication skills.
• Demonstrated ability to perform in a fast-paced environment.
• Highly developed leadership capabilities to motivate and inspire teams.
• Independently motivated, detail-oriented, and strong problem-solving ability.
• Strong customer service orientation with effective follow-through.
• Driven to excellence while encouraging process improvement and innovation.
• A leader who inspires and motivates through excellent listening skills and a willingness to mentor team members.