Vice President, Quality Assurance

Bachem AG•Vista, CA

23d

About The Position

The Vice President of Quality Assurance plays a key role in overseeing intermediate and Active Pharmaceutical Ingredient manufacturing. This position ensures that all GMP operations comply with regulatory and client requirements, as well as FDA and international standards for research, pre‑clinical, clinical, and commercial API production. Based in Vista, the VP leads the Quality Assurance teams at both the Torrance and Vista sites, ensuring adherence to all applicable laws, regulations, and industry guidance while supporting Bachem's business objectives.

Requirements

Bachelor's or advanced degree in chemistry or related life sciences field
10+ years experience in a GMP Quality setting
7+ years management experience with a proven track record leading multiple site QA organizations
Knowledge of GMP for drugs and APIs and applicable FDA regulations.
Excellent written and oral communication skills. Communicate effectively and ability to function well in a team environment.
PC proficient with ability to efficiently and productively use Microsoft Word, Excel and PowerPoint
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.
Ability to lead, motivate and mentor others
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one’s time.
Ability and willingness to be physically present at both the Torrance and Vista sites on a weekly basis

Nice To Haves

4+ years technical experience in drug substance manufacturing and/or analytical testing in the pharmaceutical industry (preferred)
Work experience at a CMO (preferred)

Responsibilities

Ensure compliance with all pharmaceutical drug, manufacturing laws, regulations, and guidance, while assuring fulfillment of Bachem’s business objectives. Stay abreast of developing GMP and other regulatory requirements and pursue continuous improvement throughout the organization.
Lead, manage and develop the Quality Assurance teams at Torrance and Vista sites. Identify and develop high-performance and high-potential individuals, actively supporting the development of their careers at Bachem. Assure the Quality Assurance team is ready to support growth of business with a pipeline of needed skillsets and potential successors for managerial and leadership positions within the Bachem organization.
Establish priorities and set goals for the Quality Assurance teams. Guide the directors and managers of the Quality Assurance teams and cultivate their ability to meet business needs and to fulfill quality and compliance requirements.
Represent Bachem during customer visits, GMP audits, and regulatory agency inspections. Ensure sites are always well-prepared and staff is prepared to respond effectively to customer and visitor questions and requests.
Provide leadership and guidance throughout the organization as a primary champion of GMP and pharmaceutical regulatory compliance.
Take an active role in achieving expected financial performance, including management of costs and diligent use of resources, and engage in budgeting and cost accounting activities
Contribute to negotiation of quality agreements with customers, suppliers, and service providers
Ensure timely and effective responses to customers and regulatory requests.
Take an active role in harmonizing and optimizing processes between the different Bachem sites, particularly between Torrance and Vista. Identify, champion, manage and participate in projects and initiatives to advance the Bachem organization.
Represent Bachem at expert conferences and congresses, preparing and providing contributing presentations when required.