Bachem

Vice President, Quality Assurance

Bachem

full-time

Posted on:

Location Type: Office

Location: Vista • California • United States

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Salary

💰 $186,011 - $255,765 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPdrug substance manufacturinganalytical testingquality assurancecost accountingbudgetingregulatory complianceprocess optimizationproject managementnegotiation
Soft Skills
leadershipcommunicationorganizationmultitaskingmentoringproblem-solvingdetail-orientedteam developmentgoal settingcustomer service