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6561 GxP Supplier Quality Contractor
1 month ago
Onsite: South San Francisco
Mission of External Quality
- We serve our patients through external partnerships because access to quality products is every patient's right.
- We leverage external partners in order to offer flexibility to our internal capacity at the right cost, speed and quality.
- We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide.
- We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.
- Provide quality expertise and compliance oversight for GMP suppliers such as Contract Development Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) for the delivery of the company's products including bulk drug substance, bulk drug product and finished goods.
- Serve as the Quality Point of Contact for designated GMP suppliers and the Company's products. Contribute as a key member of GMP supplier cross-functional management teams to select, implement and manage these suppliers.
- The ideal candidate has expertise in and experience with clinical GMP Drug Substance and/or Drug Product production.
- Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), such as due diligence and/or the company's audit assessments, risk assessments, complex investigations, and complaints.
- Develop, negotiate and maintain Quality Agreements and Product Specific Requirements with GxP suppliers, and ensure compliance with agreements.
- Collaborate with GMP suppliers to address any gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and timeliness with the supplier; and escalate as appropriate.
- Apply phase appropriate cGMP as the Quality Point of Contact on product development teams for a variety of platforms, such as large molecule, small molecule, conjugates, and oligonucleotides.
- Manage applicable activities to support disposition/release of the company's products including approval of master process and testing documentation, batch record review, resolution of investigations, assessment of changes, and ensuring cGMP compliance.
- Perform product quality risk assessments, develop mitigation plans and monitor implementation as applicable.
- Support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements.
- Batch record review;decommissioning of projects / sites;
- Quality Agreement support
- Deviation management support (assessments, info gathering ).
- Collaborate and manage relationships across GxP supplier management and internal cross-functional teams to ensure quality expectations are aligned with the company's objectives.
- Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
- Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.
- Communicate new and updated regulatory requirements and applicable the company's expectations to GxP suppliers as applicable, and evaluate systems in place.
- Support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures.
- Sign documents as authorized and described by the company's policies, procedures and job descriptions.
- Be accountable for behaviors described in the Company's Code of Conduct.
- Deliver business outcomes in support of departmental objectives.
- Maintain and communicate work priorities to meet goals and timelines.
- As part of an agile organization, flow to work and apply skills where resources are needed
- Complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.
- Identify, support and/or lead continuous improvement initiatives that benefit External Quality and other organizations.
- B.A. or B.S. degree in life sciences
- Minimum of 6 years total experience in the pharmaceutical or biotechnology industry.
- Experience with CDMO desired.
- Minimum of 2 years experience in a GMP Quality Assurance role.
- Experience with production of products used in clinical trials.
- Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers, including application of phase appropriate cGMP during product development for a variety of platforms, such as large molecule, small molecule, conjugates, and oligonucleotides.
- Demonstrated ability to apply cGMP concepts and requirements to evaluate batch disposition using sound judgment and decision making.
- Strong problem solving skills using critical thinking, identifying risk based resolutions
- Excellent verbal and written communication skills
- Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives
- Excellent influencing and negotiating skills when interacting with stakeholders at all levels within The company's worldwide operations, CDMOs and CROs.
- Adaptability to new ways of working, and an agile and innovation mindset.
- Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness.
- Fluency in oral and written English is a must.
- Additional language skills are a plus.
This position may require up to $90 to $101 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.
