QA PRODUCT RELEASE MANAGER

 

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.

 

Quality Assurance Product Release is the quality unit responsible for the disposition of Raw Materials, Bulk Drug Substance, Drug Product, Finished Product, and the GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing, and transport of products.  The QAPR staff interacts with functional units to ensure compliance with internal, external and regulatory requirements.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

  • Review and disposition Raw Materials, Bulk Drug Substance, Drug Product, and Finished Product

  • Northpointe Materials/Products:   Review/approve documentation including master batch records, specifications, SOPs, and executed batch records, prepare batch files, support testing, change controls, deviations, investigations and CAPA

  • Provide GxP oversight of Contract Manufacturing Organizations and business partners involved in the manufacture, testing, and transport of products

  • CMO Fill/Finish Products:  GxP oversight of CMOs and the Person in the Plant, review/approve master batch records, specifications, SOPs, change controls, executed batch records, testing, deviations, investigations, CAPA and prepare batch files

  • Facilitate the Periodic Product Review process and prepare the annual PPR report

  • Ensure processes align with current good manufacturing practices and industry practices/regulatory requirements

  • Facilitate updates to processes/procedures as it relates to label changes

 

ADDITIONAL RESPONSIBILITIES INCLUDE: STAFF MANAGEMENT

  • Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills

  • Ensure that functional areas of responsibility are staffed, organized and resourced to ensure compliance obligations are fulfilled

  • Provide leadership, guidance, and direction to staff consistent with GxP and corporate governance

  • Manage and develop the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance

  • Develop a cohesive team, maintain and reinforce a strong quality presence, encourage positive relationships and network effectively across functional areas

  • Ensure staff has appropriate knowledge of department processes and procedures

 

DEPARTMENT MANAGEMENT:

  • Align department objectives with site/business objectives.

  • Collaborate with Quality Director, peers and team to build and implement a long term vision for the department

  • Ensure timely issue escalation to Quality senior management and cross-functional support teams

  • Provide leadership and support teams to ensure relevant KPIs are consistently met and team members achieve their potential and meet their goal

  • Act as a subject matter expert and resource to peers and colleagues

  • Represent department or organization in project team meetings

  • Interface with external regulatory agencies as required

  • Manage cost center budget for forecasting, headcount, project allocation, and department spending as required

  • 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

 

CONTINUOUS IMPROVEMENTS:

  • Work collaboratively with inter-department and cross-functional teams to lead changes in a timely and effective manner

  • Identify opportunities to improve Quality processes and practices

  • Ensure Quality management tools/systems and documentation (SOPs, MBR's, OJTs) are accurate

 

LEADERSHIP QUALIFICATIONS:

  • Motivate, inspire, build, and retain highly effective teams while managing for high performance and developing others. They are versatile learners and courageous decision makers

  • 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

  • Delivering to Customers

  • Understand patient and customer needs and build relationships as required to meet manufacturing goals. They create a vision for the organization while continuously improving operations by holding teams accountable to high standards of performance

 

BASIC QUALIFICATIONS:

  • Bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry

  • 10 years of experience in a Quality function

  • 5-10 years supervisory and/or management experience

 

PREFERRED QUALIFICATIONS:

  • Track record in successfully managing Quality operations

  • Experience with disposition of biologic bulk drug substance, drug product, and raw materials

  • Excellent problem solver and able to generate innovative solutions to broad range of issues

  • Excellent people leadership and change leadership skills

  • Ability to set ambitious and realistic targets, drive execution and build culture of continuous improvement and accountability

 

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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Lexington, MA 02421

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