Supervisor, Quality Control-Analytical Testing

The Quality Control Analytical Testing group supports the raw material, bulk drug substance (API), drug product and in-process monitoring programs of the production facility and support areas. The group supports manufacturing activities at the Northpointe Facility through testing and release of finished drug product and the analysis and confirmation of the suitability of both the raw materials used in the manufacture of product and in-process materials generated during the different stages of the manufacturing process.

The group routinely interacts with production, engineering, validation, materials management, procurement, quality assurance and other QC groups.

Functional:

• Oversight of daily operations of QC PT/CB lab, supporting testing service needs for Manufacturing, Validation, Engineering & other Quality groups as needed.
• Supports safe, efficient, functional and compliant laboratories testing operations developed in accordance with site, corporate, and regulatory guidelines.
• Provides analytical expertise and support for product investigations, continuous improvements, etc. to ensure continued compliance with regulations.
• Develops and implements Quality Control laboratory systems that support metrics / data trending, management review, subcontractor qualification and audits for Leukine testing.
• Oversight of departmental training program.
• Oversight of departmental deviations/CAPA, change controls and laboratory investigations.
• Supports execution and continuous improvement for Drug Product, Bulk Drug Substance, In-Process and Raw Materials program(s).
• Oversees sampling and laboratory testing execution ensuring timely results produced meet quality standards and requirements.
• Identifies and prioritizes implementation of opportunities to improve Quality processes and practices.
• Works collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner.
• Reviews emerging and updated regulations and guidelines, stays current on industry trends and develop and implement gap remediation strategies with guidance from QC Manager, as necessary.
• Reviews and audits documentation to ensure accuracy, specifications and GMP Compliance.
• Participates in the development and prioritization of the Organization’s/Site’s Life Cycle Management Plan.
• Leads by example and promotes PTx’s core Values:
  Learn, Prepare, Innovate, Collaborate, Lead to continually improve the quality culture at PTx.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required time frames.
• Provides leadership and direction to the QC-Analytical Testing team and support teams to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values.
• Establishes individual goals and objectives in alignment with department goals and priorities. Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets.
• Recommends and allocates resources - human, technical, etc.
  
  - to fulfill near term goals and commitments while building towards sustainable excellence.
• Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve.
• Works pro-actively and in close collaboration with upline Leadership Team and People & Culture to recruit, hire, grow, and retain a diverse team of talent.
• Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance. Leads by example and…