Job Details
Overview:
My client is a successful, midsize client here in the Bay Area with an extensive pipeline in both the commercial and clinical stages. With numerous ongoing studies spanning various disease areas, they are dedicated to advancing the understanding and application of cortisol modulation. The Quality Operations Manager plays a crucial role in ensuring product quality and compliance across manufacturing, testing, validation, and release processes.
Responsibilities:
- Lead quality support for Chemistry, Manufacturing, and Controls (CMC) projects.
- Collaborate cross-functionally to oversee and address quality investigations at contract manufacturing and testing organizations.
- Review executed batch records, test data, and perform product dispositions.
- Review and approve validation protocols and reports.
- Conduct quality audits of suppliers, Contract Laboratories (CLOs), and Contract Manufacturing Organizations (CMOs).
- Analyze quality trends and recommend continuous improvement opportunities.
Preferred Skills, Qualifications, and Technical Proficiencies:
- Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing.
- Experience in reviewing batch records and understanding quality and regulatory requirements.
- Ability to work independently and communicate effectively with project teams and suppliers.
- Strong problem analysis and decision-making abilities.
- Proficiency in leading or supporting compliance audits.
- Excellent written and verbal communication skills.
- Familiarity with regulatory guidelines and the ability to identify compliance risks.
- Experience in authoring, reviewing, and approving SOPs and other controlled documentation.
- Strong statistical mindset and proficiency in metric presentation.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Visio.
- Travel required.
Preferred Education and Experience:
- Bachelor's or Master s degree in science, engineering, or related field.
- Must Have Small Molecule Experience
- 10 years in the bio/pharmaceutical industry.
- 5-7 years in Quality Assurance.
- Knowledge of 21CFR211, global cGMP regulations, and ICH guidelines.