VP of Quality – Pharma

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VP of Quality – Pharma

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Located in Bend, OR

Salary: Competitive comp & benefits!

A leading Central Oregon pharma team is on the hunt for an experienced quality leader within pharmaceutical manufacturing world to lead and support the Quality organization to continue to improve quality systems and compliance.

Where You Get to Live!

Bend, Oregon is the mountain town that has it all! Located in the shadows of the Cascade Mountains and surrounded by numerous lakes and rivers, Central Oregon is an outdoor enthusiast’s paradise. Check out the sights and sounds of Bend at: https://vimeo.com/200038114.

What You Get to Do!

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, 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 our 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.

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

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 implemented
Develop and implement a comprehensive Quality strategy to support the manufacturing, testing, and release of pharmaceutical products in accordance with GMP regulations and other relevant standards
Identify Key Quality and Risk Indicators (KQIs/KRIs) and oversee mechanisms for detection and trending
Oversee and manage all aspects of the Quality Management System (QMS) to ensure compliance with GMP and other applicable guidelines
Provide strategic leadership to the Quality Assurance and Quality Control Departments, fostering a culture of excellence, accountability, and continuous improvement within the GMP framework
Collaborate 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 requirements
Conduct risk assessments and implement proactive measures to prevent and address quality issues, deviations, and non-conformances within the GMP context
Lead and support regulatory inspections, ensuring readiness and effective responses to inspection findings, with a focus on GXP compliance
Establish and maintain key performance indicators (KPIs) to monitor and report on the effectiveness of the Quality Assurance program within the GXP framework
Drive the development and execution of training programs to enhance the skills and knowledge of quality personnel and other relevant stakeholders, with emphasis on GXP principles
Develop and implement Quality organizational goals aligned with the company’s vision
Develop and administer budgets, plans, and performance requirements linked to the quality Assurance and Quality Control departments
Other related duties as assigned

What You Will Bring…

Bachelors or advanced degree in scientific discipline
Minimum of 15 years of progressive experience in Quality Assurance and/or Quality Control in a pharmaceutical manufacturing environment
Previous 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 guidelines
Requires 10 years of GMP expertise
Strong leadership and management skills
In-depth knowledge of FDA regulations, GMP guidelines, and other relevant quality standards
Proven leadership experience with a track record of successfully managing and developing high-performing teams within a GMP environment
Demonstrated success in regulatory inspections and interactions, specifically within the GMP framework
Excellent verbal and written communication skills
Excellent interpersonal and customer service skills
Excellent sales and customer service skills
Excellent organizational skills and attention to detail
Excellent time management skills with a proven ability to meet deadlines
Excellent analytical and problem-solving skills with the ability to make informed decisions in complex situations, taking GMP regulations into account
Ability to prioritize tasks and to delegate them when appropriate
Ability to function well in a high-paced and at times stressful environment
Proficient with Microsoft Office Suite or related software

To Apply:

For confidential consideration, please submit resume to karen.turner@expresspros.com

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Express Office: Bend

296 Southwest Columbia Street

Suite B

Bend, OR 97702

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