Seattle based company which is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients is actively seeking a professional Quality Control Operations Manager
who is willing to relocate
to a northern Seattle suburbs - relocation package is part of the compensation for this opportunity. Immediate start date with full benefits package
The Quality Control Operations group, within the QC Department, is responsible for operational support of the lab-based testing related to the manufacturing and release of Leukine. These activities include Release/CoA, LIMS, Stability, equipment commissioning, APR/Trending, DP CMO relationship and other QC operational programs for the entire QC department.
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, bulk drug substance, Drug Product and oversight of all contract laboratory testing. Additionally, QC supports microbiological control of the utility systems and the manufacturing environment. This ensures Leukine product will meet the pre-defined standards for patient safety and product quality.
location: Lynnwood, Washington
job type: Permanent
salary: $85,000 - 100,000 per year
work hours: 9 to 5
This is a key leadership position that is responsible for the direction of the QC Operations group within the QC department that provides leadership & support to the lab-based QC testing groups and other departments for all IP, BDS, DP and FP testing.
Specific responsibilities include:
- Oversight of the sample management, BDS and DP release & stability, equipment commissioning, APR/trending, DP CMO relationships and other QC operational processes for entire QC department to ensure they are continuously meeting the regulatory, site and business needs.
- Oversight of the LIMS system to ensure QC data is organized, data output is reported appropriately, and lifecycle is maintained.
- Drive change management/implementation processes to meet established timelines.
- Provide QC expertise to support the lab-based testing functions.
- Partner with peers on oversight of training, deviations, CAPA, change controls and lab investigations.
- Develop and implement Quality Control processes/systems to streamline, digitize, align, optimize or modernize.
- Approve SOPs, reports and other documents associated with job function.
- Effectively lead QC teams and support interacting with other groups such as Quality/QA, Manufacturing, Validation, Engineering, Materials, Finance and HR.
- Represent the functional QC area in meetings and compliance activities
Additional responsibilities include: Management:
- Establish department and individual goals in alignment with site goals and priorities. Identify performance improvement targets and metrics. Ensure capabilities and capacity is in place to effectively deliver on all departmental commitments and performance targets.
- Anticipate, identify, and communicate risks across the site; while partnering to create strategies and plans to manage risk to the operations.
- Create functional excellence for area of responsibly and help integrate that capability into daily operational practices.
- Build and sustain employee engagement by creating a culture of execution and an environment within which individuals and teams can excel and continuously improve. Manage and develop the performance of direct reports by setting clear "SMART" goals, providing timely performance feedback, recognizing, and rewarding high achievers, and holding staff accountable for underperformance. Conduct performance appraisals and career development assessments for all direct reports.
- Remain current on trends and new technologies and developments in areas of responsibility.
- Obtain regular feedback from customers and stakeholders to ensure continual collaboration with cross-functional partnerships.
- Manage execution and support of departments Training Plan.
- Interface with external audit functions as needed to represent the site and Quality function or as potential host representing the site.
- Ensure all QC operations meet current cGMP and industry expectations.
- Ensure training of group has necessary training and coverage to perform duties.
- Utilize Quality Systems to measure, analyze, and improve team performance.
- Manage Investigations and CAPA for major and critical deviations.
- Ensure minor deviation are closed in a timely manner.
- Participate in internal audits and inspections conducted. Provide subject matter expertise and direct responses to agency regulators.
- Comply with requirements for Safety Program including Health and Safety regulations and OSHA requirements
- Work collaboratively with inter-department and cross-functional teams to lead changes in a timely and effective manner
- Identify opportunities to improve Quality Control processes and practices
- Ensure Quality management tools/systems and documentation (SOPs, MBR's, OJTs) are accurate
- Bachelor's degree in Science and 10 years of experience in a cGxP or other regulated environment, and demonstrated management leadership role for 3-5 years
- Experience with electronic Quality Systems (e.g. Track Wise, MasterControl)
- Strong interpersonal and professional skills to interact and build relationships with other departments and staff.
- Excellent written and verbal communication skills
- Proficiency with MS Office Applications
- Project management, commercial product, drug product manufacturing, or CMO relationship management experience desired
- Operational Excellence and proven achievements in modernizing a QC laboratory preferred
skills: Quality control, Quality Assurance, MS-EXCEL, MS-Powerpoint, MS-Project
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.