QUALITY CONTROL MANAGER
PTx is devoted to developing and commercializing medicines and combination therapies that can make a meaningful difference in the lives of patients with cancer and other serious diseases. We are united in our passion for improving the treatment of cancer and other diseases and our desire to make a meaningful contribution to outcomes. We believe that innovation is not enough. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries, and other important life moments that our patients are able to enjoy.
PTx has recently acquired global rights to Leukine (Sargramostim). Leukine is the only licensed FDA-approved GM-CSF, and PTx is investing in Leukine to position it for growth. With Leukine, PTx acquired its state-of-the-art Northpointe (NP) manufacturing facility in Lynnwood and we are North of Seattle, just a few minutes from downtown (but far enough out of, traffic and high cost of living in the city!). We are an established team with a renewed energy to seize on an exciting opportunity. PTx is a small company full of opportunities and ambition and we need outstanding people to join our team to help realize our mission.
The Quality Control Department is responsible for all testing related to the manufacturing and release of Leukine. These activities include testing raw materials, process intermediates, product and oversite of all contract laboratory testing. Additionally, QC supports microbiological control of the utility systems and the manufacturing environment. This testing guarantees the Leukine product will meet the pre-defined standards for safety, purity, identity and effectiveness. Additionally, this department works collaboratively with teams to perform method development, technical studies and investigation resolution.
POSITION OVERVIEW/KEY RESPONSIBILITIES:
This position provides key leadership and is responsible for direction of the QC department while providing scientific expertise and support to Manufacturing and Quality operations on-site.
* Support a safe, efficient, functional and compliant laboratories testing operations developed in accordance with site, corporate and regulatory guidelines
* Provide analytical expertise and support for product investigations, continuous improvements, etc. to ensure continued compliance with regulations
* Develop and implement Quality Control laboratory systems that support metrics / data trending, management review, subcontractor qualification and audits for Leukine testing
* Oversight of Quality Control departmental training program and learning plans
* Approval of Quality Control deviations/CAPA, change controls and laboratory investigations
* Support, execution and continuous improvement for Quality Control systems and programs
* Oversight of daily operations of QC lab, supporting testing service needs for Manufacturing, Quality, Validation & other groups as needed
* Effectively lead QC team supporting effective, collaborative interactions with other departments including Manufacturing, Validation, Engineering, Materials, Finance, HR other Quality groups.
* Providing leadership and direction to Quality Supervisors, direct reports and support teams to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values
* Providing development and coaching to Quality Supervisors, direct reports and support teams to achieve their potential and meet site and individual goals
* Managing, motivating and developing performance of direct reports by setting clear “SMART” goals, providing timely performance feedback and holding reports accountable for underperformance
* Recognizing and rewarding high achievers
* Ensuring timely issue escalation to Quality senior management and cross-functional support teams
* Working with recruiters to maintain staffing levels and meet approved hiring plans, conducting performance appraisals and career development assessments for all direct reports
* Developing and managing department budget
* Participate cross-functionally with internal stakeholders to review, assess and establish best practices as it relates to Regulatory Intelligence on a routine basis.
* Ensure processes and procedures are updated to reflect industry changes and regulatory expectations and escalate issues that are at risk.
* Provide departmental opportunities with regard to Regulatory Intelligence initiatives during the development of annual development plans
TRAINING / DEVIATIONS / COMPLIANCE
* Ensuring projects are managed in compliance with all PTx, regulatory and legal requirements
* Ensuring all lab operations meet current CGMP and PTx compliance requirements
* Utilizing quality systems and KPIs / QPIs to measure, analyze, and improve team performance
* Designing and managing execution of Department Training Plan(s)
* Manage Investigations and CAPA for major and critical deviations
* Ensuring all deviations and lab investigations are closed in a timely manner
* Participating in inspections conducted by internal and external agencies
* Inspection and auidt readiness preparations for lab operations and staff
* Complying with requirements from PTx’s Safety Program including Health and Safety regulations and OSHA requirements
* Work collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner
* Identify prioritize implementation of opportunities to improve Quality processes and practices
Ensure Quality management tools/systems and documentation (SOPs, MBR's, OJTs) are accurate and compliant
* PTx’s leaders motivate, inspire, build, and retain highly effective teams. They manage for high performance and provide timely developing and coaching. They are versatile learners, focused problem solvers and courageous decision makers
LEADING THE BUSINESS
* PTx’s leaders are effective operating in an evolving, complex and dynamic environment. They provide clear direction and instruction to supervisors, direct reports and teams and continuously identify internal and external best practices and opportunities for improvement.
DELIVERING TO CUSTOMERS
* PTx’s leaders understand patient and customer needs and build goals and relationships to ensure their needs and site goals are both met. They create a vision for the organization while continuously improving operations through team’s accountability to high performance standards.
*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
* Bachelor’s Degree; Chemistry/Biochemistry/Biology
* 5 years’ experience in a Manager or lead Supervisor role
* 12 years QC and/or laboratory experience in a cGMP Manufacturing Environment or equivalent
* Proven ability to efficiently lead a QC dept. responsible for all testing to release commercial product.
* Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department
* Good communication skills at individual, team and organizational levels
* Effective team facilitator with project management experience
* Operational, developmental and compliance QC knowledge in fast paced lab environment
* Detailed knowledge of quality management systems
* Effective scientific/technical knowledge of RM, Product Release, Cell Biology testing
* Ability to provide technical assay support for current assays and to lead troubleshooting/ development/re-development/validation of current and/or new assays, as needed
* Ability to plan and manage budgets/projects.
LEADING THE BUSINESS:
* Operate in an evolving, complex and dynamic environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.
* The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
Compensation and benefits are very competitive. They include a base salary, performance bonus, stock options and profit sharing. Our benefits include health, vision, dental and life INS, 401(k) with match & PTO
To be considered for the position, please send your resume to