COMPLIANCE SPECIALIST, SENIOR
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.
Quality Assurance is to provide QA oversight of the systems and procedures governing the GMP activities at the Northpointe facility including Production, Validation, Quality Control and all supporting departments.
POSITION OVERVIEW/KEY RESPONSIBILITIES:
The Compliance Specialist Senior provides oversight in company-wide, quality policies,
procedures, processes, programs, and practices, to assure the company of continuous
conformance with appropriate standards and regulations related to the manufacturing of
Completes review and approval of documentation supporting manufacturing, product testing, raw materials, and validation and maintenance/calibration activities within the facility.
Participates in investigation teams during the analysis of unplanned events or discrepancies and provide recommendations to fulfill corrective actions and compliance improvements.
Participate in teams to support the management of change events: ensure appropriate and thorough evaluation of a proposed change, adequate product assessment and compliance to regulatory fillings while facilitating continual quality improvement.
Interprets complex, explicit documentation for new and current compliance procedures and FDA enforcement action/trends.
Partner with functional groups as the point of contact for specific quality issues and complete walk-through of areas while providing feedback and fostering a collaborative relationship.
*This role currently has no direct reports to manage, but they must embody leadership skills to be successful (including effective interpersonal and cross-functional communications both written and verbal, relationship building, agility and adaptability.
Bachelor’s degree and 6-9 years of experience or Master’s degree and 4-7 years of experience and related experience in cGMP/FDA regulated industry.
Individual should have attention to detail and excellent written & oral communications skills
Scientific or Engineering Discipline
Proficiency in Microsoft PowerPoint, Word and Excel
Project Management experience
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 Brooklyn.firstname.lastname@example.org