QA COMPLIANCE SPECIALIST/AUDITOR

 

PTx is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients. We are united in our passion for improving the treatment of cancer 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 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. To get there we need outstanding people to join our team of talented, innovative and committed professionals.

 

The Quality Assurance Supplier Quality/Compliance department is comprised of three functional areas, Audit (Internal, External and Third-Party), Supplier / Subcontractor Qualification and Governance (Management Review, Quality Council and Regulatory Intelligence).  

 

The Supplier Quality /Compliance department provides strategic leadership, direction, and oversight for the site Quality function.  It is responsible for assuring inspection readiness, compliance with current good manufacturing practices and regulatory compliance requirements and assuring materials and services are procured and monitored via established systems.  

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

This role currently has no direct reports to manage, but must embody considerable leadership skills to be successful (including effective intrapersonal and cross-functional communications both written and verbal, relationship building, agility and adaptability). The role holder must mentor and inspire site personnel to achieve the company’s objectives related to human resources policies, programs, and practices.

 

This position will primarily support the audit function.  The key responsibilities of this position include administration of:

 

  1. The Internal Audit program, maintaining qualified lead auditor status, generating and maintaining the internal audit schedule, performing audits, monitoring remediation through completion/implementation.

  2. External/Regulatory Inspection, including Inspection readiness activities, inspection host/support, response management and tracking, this role also maintains and provides the Site Inspection Readiness Training as a CORE training requirement for all employees.

  3. The Third Party (Supplier/ Subcontractor) Audit program, including generation of the audit schedule, maintenance of the Approved Supplier List (ASL). 

  4. This position supports the remaining departmental responsibilities including supplier qualification and governance in a back-up capacity

 

The compliance specialist/auditor will be also:

  • Attend key conferences and industry group meetings/discussions as it relates to Regulatory Intelligence objectives.

  • 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.

  • Support the development and maintenance of Quality Standards and Policies

 

PREFERRED QUALIFICATIONS /EXPERIENCE:

  • Certified Auditor  (ASQ, ISO preferred)

  • Experience as a trainer

  • Experience participating in external agency inspections as a host (i.e. FDA, EMA)

  • Knowledge of regulatory enforcement trends

  • Experience implementing external agency regulations

 

~ 10% travel required in support of supplier qualification activities

 

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.

 

DISCLAIMER:

  • 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

 

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.borges@partnertherapeutics.com

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