Vice President, Quality Assurance

Role Overview

• 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.

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
• 4+ years technical experience in drug substance manufacturing and/or analytical testing in the pharmaceutical industry (preferred)
• Work experience at a CMO (preferred)
• Knowledge of GMP for drugs and APIs and applicable FDA regulations.
• Excellent written and oral communication skills.
• 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
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability and willingness to be physically present at both the Torrance and Vista sites on a weekly basis.

Benefits

• competitive pay
• annual performance bonus
• generous benefit package with comprehensive Medical/Dental/Vision coverage
• 401(k) plan with employer contribution
• paid vacation
• personal and sick days