Contract, Quality Assurance - GxP (GLP Focus)

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. 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 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. Bioanalytical lab experience and toxicology auditing. Registered GxP Quality Assurance Certifications. Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections. Knowledge and experience in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and/or Good Pharmacovigilance Practice (GVP) regulations. * Travel Up to 30% Hybrid based position with office in Hopewell, NJ. Expected Hourly Salary Range: $57 – $72. The hourly 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. 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. Click here to return to the careers page About Us PTC Therapeutics is a global biopharmaceutical company founded in 1998 initially focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes. As we have grown, our technology platforms have expanded from this foundational scientific expertise in RNA mechanisms to include multiple approaches including gene therapy. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders. Our internally discovered pipeline addresses multiple therapeutic areas, including neuromuscular disorders, oncology, and metabolic diseases. Our mission is to provide access to best-in-class treatments for rare disease patients who have little to no treatment options. At PTC, you are not joining a company, you are joining a cause. For more information on the company, please visit our website www.ptcbio.com. Please Beware of False Job Advertisements PTC Therapeutics is aware of employment hiring scams that make false use of our company, leader and employee names to defraud job seekers. PTC does not make job offers without interviews and we never ask candidates for money. If you have encountered a job posting or been approached with a job offer from an email address that does not use ptcbio.com, or that you feel may be fraudulent, we strongly encourage you NOT to respond. Apply tot his job