Director/Sr Director Quality Assurance, GCP
The Director/Sr Director QA-GCP is a newly created role and will be primarily responsible for the overall end to end management of Good Clinical Practice (GCP) within Constellation Pharmaceuticals. This can include conducting and reporting audits (either directly or through the use of consultants), further development of the QMS (Quality Management System), GCP quality advising and risk identification, inspection readiness, and CAPA management. Experience with Good Pharmacovigilance Practice (GVP) and Good Laboratory Practice (GLP) QA would be a bonus.
Constellation Pharmaceuticals is a pioneering epigenetics company, focused on the discovery and development of novel, small molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology.
We are currently entering late-stage clinical trials and preparing for commercialization and launch of our lead product candidate. We believe that each team member has the ability to impact and improve the lives of patients and that we are #BrighterTogether.
How you will spend your day:
- Provide leadership and direction for ongoing projects, cross-functional teams, and at management review meetings on GCP related activities/issues and act as GCP expert for Constellation.
- Develop and implement GCP compliance risk-based audit strategy and master audit plan. Includes the management, planning, conduct, approval, and close-out of audits (e.g. for a specific clinical development drug program(s) or subtype of audit). Also involves providing support and guidance during and following internal audits and external regulatory inspections.
- Provide subject matter expertise and participate in the development and review of procedural documents related to the QMS (e.g., audit, CAPA and Quality Issue Management, regulatory inspections, quality risk management).
- Participate in Inspection Readiness and inspection execution activities. This involves acting as a primary point of contact for preparation for site readiness, site inspections, and/or regulators pertaining to GCP including liaising with vendors to ensure their compliance and inspection readiness.
- Liaise with respective functions to assess job role training requirements and participate in the development and execution of GCP, SOP, or Policy related training.
- Maintain an in-depth understanding of business principles, industry trends, regulatory environment, related to GXP activities.
- To drive process improvement, provide expertise and consultative guidance on GXP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
Key Things About You:
- You will offer a minimum of 10+ years within a pharmaceutical drug development GCP related discipline (auditing, CAPA and Quality management, training and records management, SOP development and implementation).
- Bachelor’s degree, Masters/Ph.D. optional, in scientific, health sciences, or quality-related field.
- Knowledge of ICH GCP, FDA, EMA, other related ICH and general compliance and audit concepts
- Excellent communication skills, both verbal and written
- Excellent project management and leadership skills
- Able to work independently as well as in a cross-functional, multi-cultural team
- Pro-active, solution-oriented mindset and sound judgment for evaluation of risks, guidance and escalations
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at firstname.lastname@example.org
Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.