Bachem

The Vice President of Quality Assurance fulfills a critical role in intermediate and active pharmaceutical ingredient manufacturing operations.. This position maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs).. This individual oversees the Quality Assurance teams at both the Torrance and Vista, CA sites, ensuring compliance with all the laws, regulations, and guidance applicable to pharmaceutical drug manufacturing together with the fulfillment of Bachem's business objectives.. Take an active role in achieving expected financial performance, including management of costs and diligent use of resources, as well as engage in budgeting and cost accounting activities. Provide leadership and guidance throughout the organization as a primary champion of GMP and pharmaceutical regulatory compliance

vice president quality assurance

A brief overview The Vice President of Quality Assurance fulfills a critical role in intermediate and active pharmaceutical ingredient manufacturing operations. This position maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs). This individual oversees the Quality Assurance teams at both the Torrance and Vista, CA sites, ensuring compliance with all the laws, regulations, and guidance applicable to pharmaceutical drug manufacturing together with the fulfillment of Bachem's business objectives. What you will do <ul><li>Lead, manage and develop the Quality Assurance teams at Torrance and Vista</li><li>Ensure compliance with all pharmaceutical drug, manufacturing laws, regulations, and guidance, while assuring fulfillment of Bachem’s business objectives</li><li>Take an active role in achieving expected financial performance, including management of costs and diligent use of resources, as well as engage in budgeting and cost accounting activities</li><li>Establish priorities and set goals for the Quality Assurance teams</li><li>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</li><li>Identify and develop high-performance and high-potential individuals, actively supporting the development of their careers at Bachem</li><li>Assure the Quality Assurance team is ready to support growth of the business, with a pipeline of needed skillsets and potential successors for managerial and leadership positions within the Bachem organization.</li><li>Provide leadership and guidance throughout the organization as a primary champion of GMP and pharmaceutical regulatory compliance</li><li>Ensure responsiveness to customer inquiries and requests, contributing to timely and effective responses to customers RFP’s for projects and services</li><li>Contribute to negotiation of quality agreements with customers, suppliers, and service providers</li><li>Represent Bachem during customer visits, GMP audits, and regulatory agency inspections</li><li>Stay abreast of developing GMP and other regulatory requirements and pursue continuous improvement throughout the organization</li><li>Identify, champion, manage and participate in projects and initiatives to advance the Bachem organization</li><li>Take an active role in harmonizing and optimizing processes between the different Bachem sites, particularly between Torrance and Vista</li><li>Represent Bachem at expert conferences and congresses, preparing and providing contributing presentations when required</li></ul> Qualifications <ul><li>Ph.D. or Master’s degree in a science related field</li><li>Minimum of 10 years Quality experience in a GMP company</li><li>Minimum of 8 years management experience</li><li>Minimum of 5 years analytical laboratory experience in the pharmaceutical industry</li><li>Experience working at a CMO</li><li>Knowledge of GMP for APIs and applicable FDA regulations</li><li>Excellent written and oral communication skills</li><li>PC proficient with ability to efficiently and productively use Microsoft Word, Excel and PowerPoint</li><li>Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment</li><li>Ability to lead, motivate and mentor others</li><li>Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues</li><li>Detail oriented with the ability to troubleshoot and resolve problems</li><li>Ability to work independently and manage one’s time</li><li>Communicate effectively and ability to function well in a team environment</li><li>Ability and willingness to be physically present at both the Torrance and Vista sites on a weekly basis</li></ul> Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you. Base Salary Range: $185,000 - $240,000 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status

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