Serán BioScience is searching for an experienced leader within pharmaceutical manufacturing to lead and support the Quality organization to continue to improve quality systems and compliance. The Vice President of Quality plays a pivotal role in ensuring the highest standards of quality and compliance within pharmaceutical operations to establish trust with company stakeholders and clients. Emphasizing adherence to GMP regulations, the VP of Quality will lead the Quality Assurance and Quality Control teams and collaborate with cross-functional departments to drive continuous improvement initiatives.
Experience preparing and leading successful regulatory audits is required. Preference will be given to those who have direct experience leading Quality operations specific to Serán's oral solid dosage manufacturing capabilities who have a strong desire to continue to expand the integrity and capabilities of the Quality teams towards future commercial manufacturing capabilities.
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.
Supervisory Responsibilities
- Provides leadership to the Quality Assurance and Quality Control departments
- Oversees workflow of the Quality Control and Quality Assurance teams
- Develops personnel to ensure functionality across teams, high performance, and talent retention
- Integrates with the Senior Leadership Team to develop personnel and organizational effectiveness
Duties and Responsibilities
Serve as the strategic leader to drive, direct, oversee and manage quality and compliance across all departments, and ensure that quality strategies are known and implementedDevelop and implement a comprehensive Quality strategy to support the manufacturing, testing, and release of pharmaceutical products in accordance with GMP regulations and other relevant standardsIdentify Key Quality and Risk Indicators (KQIs / KRIs) and oversee mechanisms for detection and trendingOversee and manage all aspects of the Quality Management System (QMS) to ensure compliance with GMP and other applicable guidelinesProvide strategic leadership to the Quality Assurance and Quality Control Departments, fostering a culture of excellence, accountability, and continuous improvement within the GMP frameworkCollaborate with cross-functional teams, including Product and Process Development, Manufacturing Operations, Facilities Engineering, Supply Chain and Environmental Health and Safety, to ensure seamless integration of quality processes throughout the product life cycle in alignment with GMP requirementsConduct risk assessments and implement proactive measures to prevent and address quality issues, deviations, and non-conformances within the GMP contextLead and support regulatory inspections, ensuring readiness and effective responses to inspection findings, with a focus on GXP complianceEstablish and maintain key performance indicators (KPIs) to monitor and report on the effectiveness of the Quality Assurance program within the GXP frameworkDrive the development and execution of training programs to enhance the skills and knowledge of quality personnel and other relevant stakeholders, with emphasis on GXP principlesDevelop and implement Quality organizational goals aligned with the company's visionDevelop and administer budgets, plans, and performance requirements linked to the Quality Assurance and Quality Control departmentsOther related duties as assignedRequired Knowledge and Skills
Strong leadership and management skillsIn-depth knowledge of FDA regulations, GMP guidelines, and other relevant quality standardsProven leadership experience with a track record of successfully managing and developing high-performing teams within a GMP environmentDemonstrated success in regulatory inspections and interactions, specifically within the GMP frameworkExcellent verbal and written communication skillsExcellent interpersonal and customer service skillsExcellent organizational skills and attention to detailExcellent time management skills with a proven ability to meet deadlinesExcellent analytical and problem-solving skills with the ability to make informed decisions in complex situations, taking GMP regulations into accountAbility to prioritize tasks and to delegate them when appropriateAbility to function well in a high-paced and at times stressful environmentProficient with Microsoft Office Suite or related softwareEducation and Experience
Bachelor’s or advanced degree in scientific disciplineMinimum of 15 years of progressive experience in Quality Assurance and / or Quality Control in a pharmaceutical manufacturing environmentPrevious experience developing, implementing, and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelinesRequires 10 years of GMP expertisePhysical Requirements
Prolonged periods of sitting or standing at a desk and working on a computerMust be able to lift up to 15 pounds at timesNational and International travel requiredAdheres to predictable and in-person attendanceCompensation correlates to skills and experience presented by selected candidate. Visit https : / / www.seranbio.com / careers to learn more about company culture and the community of Bend, Oregon.
Benefits Summary :
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
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