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 incumbent is responsible for QA oversight and support of an in-house GLP bioanalytical laboratory, and outsourced bioanalytical and toxicology studies.
The Manager, Quality Assurance – GxP (GLP Focus) supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description:
Responsibilities:
- 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 assigned to ensure compliance with GxP regulations and guidelines including in-phase study, internal processes, data, and vendors
- Communicates audit results to internal stakeholders and writes audit reports.
- 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 coach and mentor junior staff.
- Performs other tasks and assignments as needed and specified by management.
Qualifications:
Bachelor’s degree in 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 GLP 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.
- Experience supporting regulatory agency inspections.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication 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.
- 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 requirements: Up to 30%
Expected Base Salary Range:
$123,000 - $154,800. 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.
Click here to return to the careers page
Skills Required
- Bachelor's degree in a scientific discipline
- Minimum of 6 years relevant experience in Quality Assurance or related role in pharmaceutical/biotechnology environment
- Detailed knowledge and understanding of GLP regulations
- Knowledge and understanding of OECD regulations
- Demonstrated experience leading and/or conducting QA audits
- Demonstrated experience developing and executing risk-based audit plans
- Experience assessing audit responses and ensuring closure of CAPAs
- Experience supporting regulatory agency inspections (e.g., FDA, EMA, MHRA)
- Ability to develop and foster collaborative relationships with internal staff and external vendors
- Proficiency with Microsoft Office
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively in a fast-paced, matrixed environment
- Strong analytical, problem-solving, planning, organization, and time management skills
- Experience writing and reviewing SOPs
- Bioanalytical laboratory experience
- Registered GxP Quality Assurance certifications
- Knowledge and experience in GCP, GMP, and/or GVP regulations
What We Do
PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare and serious disease
