Director, Quality Assurance - Bethesda, United States - August Bioservices

August Bioservices Bethesda, United States

3 weeks ago

Description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO).

As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.

Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow.

To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility.

For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August

August Bioservices is seeking a Director, Quality Assurance to join our growing team Reporting to the VP, Quality, the Director of Quality Assurance is responsible for the administration and oversight of the Quality Management System to ensure compliance with the requirements of regulatory authorities, cGMP and customers.

This role must have the ability to recruit, coach, and retain highly effective multidisciplinary teams, and influence cross-functional consensus to deliver on project milestones and business objectives.

Responsibilities
Implement, coordinate, and administer the Quality Management System, including the following activities and programs:
Internal and external audits
Batch disposition and release
Change Control
Document Control
Training
Investigations and CAPA
Acceptance sampling
Develop and maintain fiscally responsible budgets and meet targets
Build, develop and lead dynamic Quality Assurance team
Communicate clearly and professionally with cross-functional teams and customers
Ensure GxP compliance of all August products and services
Ensure customer expectations are met or exceeded
Availability to travel domestically and internationally
Qualifications
Bachelor's degree in science or other related discipline
A minimum of 5 years management/leadership experience in the pharmaceutical industry
Must have significant knowledge of and extensive experience with injectable drug manufacturing, including aseptic processing, terminal sterilization and lyophilization

In-depth knowledge of cGMPs and other global regulations and guidelines related to the manufacture of APIs and drug products is required.

Experience with electronic Quality Management Systems is desired.
Experience with Pharmaceutical Development and Clinical Trials is desired.
Excellent written and verbal communication skills required.
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives.

We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement.

We aspire to unlock the potential in every person, every process and every molecule – from start to finish.

We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements.

We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices.

We are pointing the way forward. If this sounds like

your

kind of working environment, we want you on

our

team
August Bioservices is an equal opportunity employer and values diversity.

All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs.

August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

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