Manager, Quality Assurance - GxP (GCP Auditing) Remote

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

The Manager, Quality Assurance – GxP (GCP Auditing) is responsible for executing GxP Quality Assurance (QA) auditing functions with an emphasis on Good Clinical Practice (GCP) quality systems that govern compliance programs for PTC clinical activities.

This involves engaging and collaborating with cross functional internal teams to evaluate Clinical processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

The incumbent is responsible for continuous improvement of a risk-based audit program, qualification requirements for audits, and the inspection management process. In addition, the incumbent supports and/or conducts internal and external GCP audits of vendors including clinical research organizations (CRO), laboratories, and specialty services.

He/she will assist in inspection readiness activities.

The incumbent works cross-functionally with internal departments and external resources on GCP QA related issues and may assume additional responsibilities as required.

The Manager, Quality Assurance GxP (GCP Auditing) supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Responsibilities

• Contributes to the execution of the PTC audit strategy to maintain GCP compliance with applicable regulations, guidelines, and current regulatory requirements.

• Performs internal and external audits as assigned to assure compliance with GCP regulations and guidelines.
  • Communicates audit results to internal stakeholders and writes audit report.
  • Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).
• Participates in regulatory authority inspections and assists with GxP inspection readiness activities.
• Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service to the organization.
• Ensures appropriate and timely escalation of quality issues, including issues of significant findings to QA Management and makes appropriate recommendations for correction and improvement as may be necessary.
• Engages in quality system continuous improvement initiatives to enforce the quality culture.  

• Performs other tasks and assignments as needed and specified by management.  

Qualifications

• Bachelor’s degree in a scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.

• Detailed knowledge and understanding of GCP regulations.

• Demonstrated experience leading and/or conducting QA audits.

• Demonstrated experience developing and executing risk-based audit plans.

• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.

• Proficiency with Microsoft Office.

• Excellent verbal and written communication and skills.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. 

• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience writing and reviewing SOPs

• Clinical lab experience.

• Registered GxP Quality Assurance Certifications.

• Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections.

• Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Pharmacovigilance Practice (GVP) regulations.

* Travel requirements

Up to 45%

Expected Base Salary Range:

$107,100 – 134,800.  The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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