Senior Vice President of Quality Assurance

2 weeks ago

Vista, California, United States CLevelCrossing Full time

Company Overview
The Swiss-based Group is a publicly traded, innovation-focused organization that excels in the development and production of peptides and oligonucleotides. As a comprehensive service provider, the company offers products for both clinical development and commercial applications, alongside an extensive catalog and specialized custom synthesis.

With five decades of expertise and branches in various countries, the Group is recognized as a preferred partner for the global biotech and pharmaceutical sectors.

Role Overview
As a vital member of the Executive Committee, the Senior Vice President of Quality Assurance plays a crucial role in overseeing the manufacturing operations of intermediate and active pharmaceutical ingredients. This position is responsible for managing the Quality Assurance teams across multiple sites, ensuring adherence to all relevant laws, regulations, and guidelines pertaining to pharmaceutical manufacturing while aligning with the company’s strategic objectives.

Key Responsibilities
- Lead, manage, and nurture the Quality Assurance teams at designated locations.
- Ensure compliance with all pharmaceutical manufacturing laws and regulations, while supporting the company’s business goals.
- Actively participate in achieving financial targets, including cost management and resource allocation, as well as engaging in budgeting and financial oversight.
- Establish priorities and set objectives for the Quality Assurance teams.
- Mentor and guide directors and managers within the Quality Assurance teams to meet business needs and fulfill quality and compliance standards.
- Identify and cultivate high-potential individuals, fostering their career development within the organization.
- Ensure the Quality Assurance team is equipped to support business growth, with a pipeline of necessary skills and potential successors for leadership roles.
- Provide leadership and direction as a primary advocate for Good Manufacturing Practices (GMP) and regulatory compliance.
- Respond to customer inquiries and requests, contributing to timely and effective project proposals and service agreements.
- Assist in negotiating quality agreements with clients, suppliers, and service providers.
- Stay informed on evolving GMP and regulatory requirements, pursuing continuous improvement initiatives across the organization.
- Collaborate to harmonize and optimize processes between various sites.

Candidate Profile
- Ph.D. in a science-related field with a minimum of 5 years of industry experience, or a Master’s Degree with at least 8 years of relevant experience.
- Over 10 years of overall experience, including 5 years in a managerial capacity within the pharmaceutical or medical device sectors.
- In-depth knowledge of GMP for active pharmaceutical ingredients and applicable FDA regulations.
- Exceptional written and verbal communication skills.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Strong organizational skills with the ability to multitask in a fast-paced environment.
- Proven leadership abilities, with a focus on motivating and mentoring team members.
- Detail-oriented with strong problem-solving skills.
- Ability to work independently and manage time effectively.
- Collaborative team player with effective communication skills.

Preferred Qualifications
- Experience in a Contract Manufacturing Organization (CMO).
- Technical background in drug substance manufacturing.

The Company is an equal opportunity employer, making employment decisions without regard to an individual's disability, religion, or any other basis prohibited by law.

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