COMPUTER SYSTEM VALIDATION/DATA INTEGRITY 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 Validation department is responsible for ensuring that the site and corporate processes, equipment and systems are maintained in a qualified state.

 

The Manager of the Computer System Validation (CSV) and Data Integrity (DI) group will be responsible for ensuring that CSV/DI aspects of GMP equipment, processes and practices are in compliance with current industry expectations.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

The position will provide expertise and support to our internal business units through the interpretation of government regulations and guidelines, as well as industry best practices.  The individual filling this role will develop and/or modify site and corporate programs as it relates to meeting Partner Therapeutics CSV/DI objectives.

 

CSV/DI Manager, will be responsible for the following, but not limited to:

  • Ensure GMP computerized systems are validated and controlled to comply with US and ICH Q7 guidelines

  • Prepare or review all levels of validation documents (internal and external Software Design Life Cycle (SDLC)) including:

    • Validation (Strategy) plans, User Requirements Specifications

    • Definition documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOP’s

    • Qualification Documents and test Specifications (DQ, IQ, OQ, PQ/FATs/ SATs)

    • Traceability Matrices, Risk Analysis

    • Validation Reports, Change Controls/Events/Deviations etc.

  • Manage group projects and workload to support the validation lifecycle of GMP computerized systems

  • Support investigation of CSV defects and quality records (Deviation, CAPAs)

  • Development, execution and approval of computer system change control records

  • Act as subject matter expert for CSV during regulatory inspections

  • Provide support to internal and external audits related to computerized system validation activities

  • Mentor a team of CSV professionals and enable their individual grow

  • Provide oversight and management of Partner Therapeutics’ Data Integrity Program

  • Perform DI assessments of current practices, procedures, and system functionality, including physical and logical security, electronic signatures, audit trails, data mapping, record storage and retention periods, computer system validation, infrastructure qualification, back-up/restore, archival, software supplier qualification and quality agreements, and investigation of data integrity issues

  • Support internal and external audits and regulatory inspections around data integrity concepts

  • Partner with site QA to provide quality oversight of DI related issues

  • Partner with site QA to develop and facilitate DI training

 

LEADING PEOPLE

  • 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.

 

BASIC QUALIFICATIONS:

  • BA/BS in a relevant field with 10+ years or MS in a relevant field with 8+ years relevant GMP and/or validation experience

  • 5+ years of experience in CSV

  • 3+ years of experience in managing direct reports.

  • Strong working knowledge of computerized system validation following industry standards (GAMP), and cGMP is required, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance

  • An in-depth understanding of Data Integrity principles and current industry best practices is required

  • High Attention to detail

  • Previous experience working with/within Quality Management Systems (Deviation, CAPAs, & Change Management)

  • Excellent written and oral communication skills

  • Ability to proactively identify and implement continual improvements

  • Proven ability to work effectively in a fast paced team environment

Responsible for goals, metrics and growth of your direct reports as a group and individually

 

PREFERRED QUALIFICATIONS:

Preferred qualifications are additional qualifications or experience that would make an individual ideal for the job. However, if the individual does not have these qualifications, it does not disqualify them from being considered for the job.

  • Experience leading regulatory inspections in regards to CSV and/or DI

  • Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude

  • Ability to partner with internal and external stakeholders; sharing information to increase the collective understanding of QA and Data Integrity programs.

  • Experience interacting with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.

 

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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(781) 218-9394

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19 Muzzey Street

Lexington, MA 02421

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