Quality Specialist

Local Candidate Needed

The Position

We thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. 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 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.

The Opportunity

• Provide quality and GMP compliance oversight of CDMO / CRO operations for the delivery of products to clinical trials, including bulk drug substance (API) and bulk drug product for multiple technical platforms
• Ensure cGMP compliance and execute activities in support of disposition of clinical API and Drug Product manufactured at CDMOs, including but not limited to :
• Approval of master process and testing documentation
• Batch record review
• Leading and approving complex investigations
• Assessing and approving changes
• Ensure project milestones as well as expectations such as on time closure are met.
• Execute activities in support of global clinical trials, such as the Product Specification File
• Oversee and execute all required quality activities during the lifecycle of a CDMO / CRO, including but not limited to :
• Negotiation and maintenance of Quality Agreements
• Monitoring cGMP compliance, identifying and mitigating quality risks
• Supporting audits, ensuring audit responsiveness and CAPA implementation

Qualifications and Skills

B.A. or B.S. degree in life sciences

Minimum of 6 years experience in the pharmaceutical industry.

Minimum of 2 years experience in a GMP Quality Assurance role.

Must have experience making GMP release / disposition decisions and associated approval of master process and testing documentation, batch record review, resolution and quality approval of investigations, assessment of changes for clinical API and / or Drug Product, preferably synthetic molecules. Experience with SAP and Veeva is a plus. Experience with CDMO desired.

Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to CDMO / CRO, especially application of phase appropriate cGMP during product development for a variety of platforms, such as large molecule, synthetic 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. Fluency in oral and written English is a must.

Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives