Head of Quality
The Head of Quality is a newly created position and will have the opportunity to define and further build the Quality function/QMS at Constellation. This leader will work cross-functionally to create and maintain standards for GXP compliance and will have a high degree of impact across the organization. The Head of Quality will bring a proven track record of building, leading and executing Quality activities for all GxP functions.
Constellation is 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:
- You will provide leadership, guidance and context to the GXP Quality organization as well as provide the vision and strategy for Quality as an integral part of Constellation Pharmaceuticals
- You will champion a proactive and phase-appropriate approach to Quality, including creating and overseeing the GXP Quality Framework and a QMS that is phase appropriate, scalable and sustainably compliant
- You will establish and maintain policies and procedures (SOPs) and accompanying systems related to GXP compliance in adherence to US and international regulatory requirements
- You will engage cross-functional stakeholders to align on and achieve Quality related objectives
- Execute independent oversight of product quality decisions and GXP activities
- Represent Quality initiatives and decisions across a broad range of departments and levels of management including the Senior Leadership Team
- Act as a primary point of contact for preparation for site readiness, site inspections and/or regulators pertaining to GXP
- You will partner cross-functionally on all levels to select appropriate contract organizations in order to ensure effective, clear agreements are in place to execute and monitor Quality accountabilities, including but not limited to inspection management
- Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GXP activities
Key Things About You:
- You will hold a Bachelor’s degree preferably in a scientific or technical discipline; advanced degree preferred
- You will have a minimum of 15 years’ experience in the pharmaceutical industry with a minimum of 10 years’ in a quality management role.
- You will have a proven leadership ability to align, motivate and empower teams
- Excellent knowledge of regulations, policies, and guidance in the US and ICH regions related to quality oversight of manufacturing and controls, clinical and nonclinical research, and pharmacovigilance.
- You will be able to demonstrate success in preparing for and leading inspections by the FDA and other regulatory agencies.
- You will have had success with anticipation and prevention of long-range problems. Strategic effectiveness in long-term problem-solving.
- You are an expert in navigating matrixed organizations and working effectively with all levels of management, cross-functional stakeholders, and individual contributors across the company
- A strong team player that has a customer service approach and is solution-oriented.
- You are known for your attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication and presentation skills.
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.