Senior Manager / Associate Director, CMC
San Diego, CA
- We are seeking a responsible, dynamic, creative and highly motivated Senior Manager or Associate Director, CMC to join our Quality Assurance department.
- This role will provide technical compliance and oversight of contract manufacturing, testing, research, and/or laboratory organizations.
- This is a full-time position in the company’s San Diego headquarters.
- The title will be dependent upon experience level.
- Providing quality and compliance oversight of the quality systems at Samumed and those of contract manufacturing, testing, research and/or laboratory organizations including, but not limited to: product complaints, deviations, OOS investigations, document creation and control, site audits, change control, validation (e.g., process, cleaning, analytical method, etc.), stability, batch record review, and product disposition
- Proactively managing Contract Manufacturing Organizations (CMOs) according to Samumed’s quality standards to support the multi-product portfolio of clinical development programs
- Providing technical expertise and guidance to CMOs by supporting or managing deviations, investigations, changes, risk assessments and CAPAs
- Working effectively and collaboratively with external vendors and cross-functional teams, such as pharmaceutical development, manufacturing, quality control, regulatory affairs, and program management
- Providing guidance functionally and cross-functionally; managing work activities of peers and contractors for specific projects or objectives as required
- Managing batch disposition activities to ensure that products are dispositioned in accordance with cGMP, Samumed policies and procedures, and project timelines. Communicating any delays or significant quality issues in a timely manner. Addressing any lot disposition documentation requests in support of clinical trials
- Partnering with CMO quality organizations to ensure timely and appropriate batch disposition.
- Supporting the development, implementation and maintenance of quality systems to maintain oversight of CMOs, CROs and contract labs, including but not limited to; document control, change control, investigations, deviations, CAPA, and product/customer complaints. Writing and/or reviewing associated SOPs, forms, and templates
- Providing support for quality audits at CMOs including the implementation and monitoring of audit related CAPAs
- Participating in the review, evaluation and approval of contract manufacturing, testing, research and/or laboratory facilities
- Reviewing and approving GMP-related documents as requested and appropriate
- Ensuring that documents and records are kept in compliance with regulations and SOPs
- BA/BS in a scientific field of study
- At least 10 years of relevant experience in manufacturing and or quality assurance
- Sound knowledge of the drug development process
- In depth understanding and application of industry standards and cGMP/international regulations and guidelines
- Risk assessment experience and understanding of risk management principles. Familiarity with risk based approaches suitable for bio-pharmaceutical development
- Advanced ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to successfully manage a full workload across multiple-projects
- Ability to manage vendor compliance
- A flexible attitude with respect to work assignments and continued industry related education
- Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
- Ability to handle even difficult situations professionally and maintain a professional and caring demeanor
Please submit your resume or additional inquiries to firstname.lastname@example.org