Manager, Quality Control

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Description:

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. This position oversees core activities such as in process testing and micro testing. The role includes oversight of raw material, in process, and reviewing release testing of GMP products to support our clients, interacting with Clients concerning project specific QC issues, approving department cGMP documents, contributing to cGMP reports, and managing QC staff as necessary to achieve these tasks.

ESSENTIAL DUTIES AND 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
• Leading 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 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
• Other tasks as assigned by management.

QUALIFICATIONS:

Required:

• 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
• Experience in the Management of +5 people

Preferred:

• Prior experience in a CMO or dealing with CMOs preferred
• 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
• Independently motivated, detail oriented and 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

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

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.