Vice President, Quality Operations

Job Title: Vice President, Quality Operations

Job Details:

Please carefully review the position requirements before submitting a potential candidate for consideration.

Job Summary

We are seeking a VP, Global Quality Operations to oversee global quality operations. The responsibilities of this position include, but are not limited to, managing client and external CMOs quality operations and the batch release process of commercial and clinical stage products. Additionally, the individual is expected to establish and maintain a robust quality system at all manufacturing sites to support production of safe, effective and quality commercial and clinical products. This strategic leader is also expected to hire, mentor and develop the global quality operations team. This position reports to the Global Head of Quality and will be a member of the Senior Quality Leadership team.

Essential Functions

·        Define, implement, and execute global strategy with US and ex-US CDMO partners and our sites to ensure product is consistently developed, manufactured, tested, labeled, released, and shipped to meet domestic and international regulatory requirements. This includes interface and management of Qualified Persons (QPs) at all applicable sites and regions.

·        Responsible for global product releases of drug substance, drug product and finished goods for commercial as well as clinical stage programs.

·        Develop global quality operational strategies by establishing critical quality and operational metrics and measurements; conducting trend analysis; system design and implementation.

·        Provides mentorship, leadership, and development opportunities to the global quality operations’ team to maintain talented capable and agile team.

·        Builds and promotes a culture of Operational Excellence within the quality operations group and the overall QA.

·        Stays current and is an internal subject matter expert for changes in GxP expectations, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.

·        Effectively cooperates with departments across and partner sites to analyze and resolve technical issues in accordance with appropriate and relevant quality standards.

·        Ensures alignment with applicable site and regional offices to global regulatory requirements for the manufacture, distribution and release of drug substance, drug products and adjuvants to all approved regions of the world to support commercial and clinical stage programs.

·        Develops and provides quality oversite of all batch release sites and regions compliant with the to the regulatory requirements of the region.

Supervisory Responsibilities

·        Minimum of 10 years supervisory experience

Required Knowledge, Skills, and Abilities

·        Knowledge and experience in principles of current Good Manufacturing Practices (cGMPs) , Good Distribution Practices, and Good Laboratory Practices (GLPs) of global regulatory expectations

·        Experience with analytical methods, method qualification, validation, and technology transfer

·        Demonstrated verbal and written skills in communicating regulatory and technical information.

·        Strong command of the English language and demonstrated editing skills.

·        Flexible and adaptable to changing priorities. Ability to work under pressure within tight timelines.

·        Strong interpersonal skills and sense of business ethics

·        Experience in project management

·        Excellent time management and organizational skills and attention to detail

Education, Experience, Licenses & Certifications

·        B.S. in scientific discipline required. Advanced degree in the biological sciences discipline is preferred

·        Minimum of 15 years Quality Assurance experience in pharmaceutical, biologics and/or vaccine manufacturing