Manager, Quality Control

About the role

This position is responsible for the daily QC oversight of PCI’s laboratory functions. This includes all operational and technical activities in delivering quality chemical, biopharmaceutical and microbiologic testing services to our customers.

Responsibilities

• Provides 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.
• Maintains 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 that effective corrective action is implemented.
• Working with project teams to represent Quality Control, conducting risk assessments and introducing best practices into the Quality Control processes.
• Manage and develop professional and technical skills and performance of department members.
• Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary.
• Supporting regulatory information requests from customers as it pertains to QC.
• Supporting 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.

Requirements

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

Qualifications

• Demonstrates 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.
• Independent and detail-oriented with good problem-solving ability.
• Demonstrates a strong customer service orientation with effective follow through.
• Driven to excellence while encouraging others to engage in process improvement and innovation.
• A leader who inspires and motivates, through excellent listening skills and a willingness to mentor team members.

Skills

• Substantial knowledge of subject matter, industry best practices and trends.

Benefits

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

Pay

N/A

Schedule

N/A

Benefits

N/A

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