Contract, Quality Assurance - GxP

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

Job Description Summary:

The Contract, Quality Assurance - GLP is responsible for GxP Quality Assurance (QA) functions with an emphasis on Good Laboratory Practice (GLP), compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

They may manage direct reports.

The incumbent is responsible for QA oversight and support of an in-house GLP / GLCP bioanalytical laboratory, and outsourced bioanalytical and toxicology studies.

The Contract, Quality Assurance – GLP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

ESSENTIAL FUNCTIONS

                                                                                                                                         

• Partners with PreClinical Development Drug Metabolism and Pharmacokinetics (DMPK) and Toxicology departments to ensure GLP compliance. Reviews and approves study-related documents and plans including method development, method validation, and study data.

• Performs internal and external audits as assigned to assure compliance with GxP regulations and guidelines including in-phase study, internal processes, data, regulatory filings, and vendors)
  • 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.

• May manage, coach, and mentor junior staff.
• Performs other tasks and assignments as needed and specified by management.

JOB DESCRIPTION

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

                                                                                                                    

• Minimum level of education and years of relevant work experience:                                                                                                                              

• 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.

• Special knowledge or skills needed and/or licenses or certificates required.                                                                                                                              

• Detailed knowledge and understanding of FDA GLP (21 CFR Part 58) and OECD 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.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.

• Ability to influence without direct authority.
• Experience supporting regulatory agency inspections.

• 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 abilit