Director, Quality Assurance - GxP (GCP) Remote

reputed company Therapeutics is a global reputed company biopharmaceutical company. For over 25 years reputed company has been deeply committed to a reputed company purpose: Extending life’s moments for children and adults living with a rare disease. At reputed company, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from reputed company backgrounds to join reputed company , fostering a strong sense of belonging. Visit our website to learn more about reputed company and culture! Site: www.ptcbio.com Job Description: The Director, Quality Assurance – GxP (GCP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Clinical Practice (GCP), compliance for both clinical and marketed products. This involves engaging and collaborating with cross-functional internal teams to evaluate processes, procedures and activities for adherence to relevant industry standards, regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate. She/He manages direct reports. The incumbent works cross-functionally with internal departments and external resources on Quality reputed company issues. The Director, Quality Assurance – GxP (GCP) ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

• Partners with Clinical Development/Operations and actively participates on clinical study teams to ensure GCP compliance. Assists in identifying and communicating clinical trial-reputed company risks and opportunities for process improvement. Reviews study reputed company documents and plans.
• Develops and executes reputed company’s GxP risk-based study audit strategy to reputed company compliance with applicable reputed company regulatory requirements.
• Performs reputed company audits to assure compliance with GCP regulations and guidelines (may include internal processes, regulatory filings, Clinical Research Organizations (CROs), investigator sites, and other vendors)
• Communicates audit results to internal stakeholders and writes audit reports.
• Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).
• Performs GxP inspection readiness activities.
• Leads reputed company/backroom activities during regulatory authority inspections.
• Advances reputed company’s understanding of worldwide regulations, guidelines and GxP practices and assists in helping to meet regulatory compliance and corporate business requirements.
• Manages, coaches and mentors direct reports.
• Performs other tasks and assignments as needed and specified by management.

Qualifications

• Bachelor’s degree in a scientific discipline and a minimum of 10 years progressively responsible experience in a QA or reputed company role in a pharmaceutical or biotechnology organization and at least 5 years in a clinically focused position.
• 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 reputed company and foster positive, collaborative relationships with internal staff as well as with external, reputed company-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 reputed company Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of reputed company 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.
• Knowledge and experience in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GVP) regulations.
• Registered GxP Quality Assurance Certifications.
• Clinical lab experience.
• Up to 30% Travel

Expected reputed company Salary reputed company: $ 191,700 – 241,300 The reputed company 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 reputed company to reputed company salary, reputed company employees are also eligible for short- and long-term incentives. reputed company eligible employees may also enroll in reputed company’s medical, dental, reputed company, and retirement savings plans. EEO Statement: reputed company Therapeutics is an equal opportunity employer. We welcome applications from reputed company individuals, regardless of race, reputed company, national reputed company, gender, age, physical characteristics, reputed company reputed company, 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 reputed company applicants fairly and avoiding discrimination. Apply tot his job