Director/Senior Director of Quality
Position Summary
As Director/Senior Director, Quality, you will play a leadership role in establishing the company’s Quality program to ensure that Biomea, as a clinical stage company, is in full compliance with all applicable Regulatory requirements. In this role, you will be identifying and preparing all needed Standard Operating Procedures (SOPs) for GCP clinical trials and GMP manufacturing. In addition, you will be responsible for any GLP activities conducted by the Biomea. After the preparation of the SOPs, you will ensure that all GxP activities are conducted in compliance with applicable regulations, guidelines, company procedures and protocols. You will need to build the Quality department by hiring the necessary staff as needed, and development/maintenance of GxP related quality system.
Key Accountabilities/Core Job Responsibilities
- Develops an over-arching Corporate Policy on Quality;
- Identifying and leading the preparation of the needed SOPs to ensure all company GxP activities are conducted in full compliance of all applicable Regulatory requirements;
- Initiates and manages the review and approval of SOPs and supports department infrastructure development
- Ensures the establishment of audit plans to ensure:
- - Clinical trials are conducted and GMP products are manufactured in compliance with applicable study protocols and regulatory requirements;
- -GMP products are manufactured and tested according to established MBR and Analytical methods and are released for appropriate uses.
- Leads and trains others to adhere to Corporate Policy on Quality;
- Provided expert GxP advice to assure best Quality Assurance practices;
- Leads the administration of the company’s training program and conducts GxP training of staff as needed;
- Hosts Regulatory Authority inspections and ensures inspection readiness.
Education and Training
- Minimum BS/BA degree in biological sciences, chemistry, or related field.
- Society of Quality Assurance Registered Quality Assurance Professional in GCP and/or GLP preferred.
Experience
- 15 years of progressive pharmaceutical/biotechnology experience in a pharmaceutical company;
- Minimum 10 years direct US and International auditing experience, inclusive of developing quality systems and supporting regulatory authority inspection.
Specific Skills
- Excellent working knowledge and understanding of GxP related requirements and proficiency of regulatory requirements;
- Broad experience in the pharmaceutical industry with clinical development background;
- Ability to work well with all functions;
- Ability to prioritize work and can manage multiple conflicting priorities.
- Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
Industry
- Biotechnology
Equal Employment Opportunity
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.