Sr Manager, QA Raw Materials
San Diego, CA
Quality – Quality Assurance /
Full Time /
On-site
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Sr. Manager, QA Raw Materials will be accountable for maintaining compliance to regulations for all raw materials used in GMP areas. The Sr. Manger will be responsible for ensuring the site performs in a state of compliance by leading and supporting all Quality oversight activities related to the raw materials testing and release.
Responsibilities
- Provides QA oversite of Raw Material release
- QA responsibilities for Raw Materials sampling, disposition, and Qualification
- Raw Materials Specifications review/approval
- Recruit, supervise and develop a strong quality team.
- Develop and implement Quality strategic initiatives in support of Abzena’s long range plan, as a member of the QLT.
- Play a bigger role within Quality to drive site and cross site initiatives.
- Participate in client and regulatory inspections.
- Motivate the team to ensure consistent timely disposition of raw materials.
- Maintain consistent communication with programs/project managers to understand customer needs and timelines.
- Identify and lead the execution of efficiency projects for the area.
- Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Prioritize and manage workload for multiple projects and tasks simultaneously to successfully meet goals and objectives.
- Review/approve protocols, reports, method SOPs, etc
- Support day to day operations and provide cross functional support to the Quality Assurance and Quality Control Team at San Diego and Bristol as needed.
- Operate in both a team and individual setting with minimal supervision.
- Operate to the highest ethical and moral standards.
- Comply with Abzena's policies and procedures.
- Communicate effectively with clients, supervisors, colleagues at both sites and staff in both verbal and written format.
- Participate effectively as a team player in all aspects of Abzena's business.
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
Qualifications
- Bachelor’s degree in science or engineering with 7-10 years of relevant experience including leading and developing teams.
- Relevant experience as a quality leader.
- Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development and commercial.
- Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
$130,000 - $150,000 a year
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
