Job Description Summary: The Senior Manager, Quality Assurance - GxP (GLP Focus) is responsible for managing 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.
She/He will manage direct reports.
The incumbent is responsible for QA oversight and support of an in-house GLP bioanalytical laboratory and outsourced toxicology and bioanalytical studies.
The Senior 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), Toxicology, Pharmacology and Biomarker, and early development departments to ensure GLP compliance. Reviews and approves study-related documents and plans including method development, method validation, and study data.
- Manages and 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 leads GxP inspection readiness activities.
- Manages, coaches, and mentors direct reports.
- Performs other tasks and assignments as needed and specified by management.
Qualifications:
- Bachelor's degree in scientific discipline and a minimum of 7 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.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- 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:
$139,700 - $175,800. 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.
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