Vice President of Quality
Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.
Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Vice President of Quality is a tenured and experienced individual in biological drug product manufacturing responsible for providing key leadership, vision, organizational direction, change management, compliance monitoring, CGMP compliance, and function as independent and objective subject matter expert responsible at both a strategic and tactical level. This individual will pursue proactive enhancement of all aspects of compliance, quality, and risk management. The successful candidate in this position will be able to build a strong, effective, and diverse team to support the ever-changing global regulatory landscape and ensure that the quality needs of our clients are met. This individual must understand how to build strong relationships with both domestic and international regulatory authorities.
Primary Responsibilities:
- Develops and implements commercial quality strategies related to client and Aldevron Products.
- Directs the review and provides quality guidance on related activities, ensuring adherence to commercial requirements for submissions.
- Lead and support all Quality Assurance, Quality Control, and QMS activities and functions.
- Develop the technical, Quality, and business acumen of our Quality department.
- Interacts with clients and key stakeholders internally to address and resolve difficult Quality problems
- Acts as primary liaison and coordinates meetings with FDA and other health authorities as needed, representing the company with those agencies.
- Provide daily leadership and management for the teams that report into this position to drive excellence in quality related functions.
- Drive the development and implementation of new processes and procedures that will enhance efficiency and compliance
- Proactively identify potential quality risk areas and then drive the implementation of appropriate corrective and preventive actions.
- Train, mentor, and coach the staff within the department
- Communicate the company’s Quality standards to the entire Quality team, Site Managers, and the Site Leadership Team
- Interact and partner with our operational counterparts to build strong relationships, to enhance and improve our Quality culture, and reduce the number of non-conforming events encountered during manufacturing.
- Write, review, and/or revise standard operating procedures as needed.
- Works productively with cross functional teams within the organization in order to proactively resolve issues.
- Participate in any issues that require management escalations
- Provide support for internal projects in order to ensure that everything is appropriately documented.
- Maintains effective and collaborative internal customer relationships
Supervisory Responsibility:
- This individual with lead a team of Quality professionals that are responsible for final product release, shop floor inspections and operational oversight, regulatory affairs and compliance, and the testing, inspection, and release of incoming raw materials required for manufacturing.
Experience:
- Minimum 15 years of experience in a Quality, preferably at a senior leadership level
- Experience working in a regulated or GMP compliant environment
- Experience working in biological drug product manufacturing environment
- Current or past Quality certifications a plus (e.g., ISO 9001, ASQ, etc.)
- Sterile and/or aseptic manufacturing experience
- “Hands on” experience and attitude is a must
- Varied experience in many areas of Quality is a plus (i.e., Quality Assurance, QC Testing, Validation, Microbiology, Regulatory Affairs, Compliance, etc.)
Education:
- Bachelor of Science, required; life science related field, preferred or equivalent experience
- Graduate level education is a plus
Skills & Knowledge:
- Strong organizational and leadership skills
- Demonstrated effective communication and interpersonal skills across all functions
- Experience in process understanding as it pertains to cGMP manufacturing and QA release
- Comprehensive understanding of cGMP manufacturing expectations
- Ability to works independently or as a team player when cross-functional involvement is involved
- Critical thinker with strong decision-making skills
- Leadership or team management experience
Abilities:
- Ability to manage priorities, track progress of key projects, and provide updates to leadership as required
- Ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
- Ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations
- Ability to effectively lead and motivate a team of direct reports, provide unifying vision, build on strengths, and address areas of improvement
- Ability to establish professional relationships and rapport with internal and external peers and higher-level management
- Ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions
- Ability to build effective working relationships with key business partners, customers, suppliers, and peers
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.