Job Description
Vice President, Quality Assurance Dublin
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research.
- The VP Quality Assurance will proactively develop, lead and drive the execution of the quality assurance strategy across commercial & clinical manufacturing activities as well as commercial affiliate activities by overseeing organizational and programmatic elements of the company’s corporate quality control, quality assurance and quality compliance functions.
- The position holder will serve as a key and active member of the Technical Operations leadership team and interact with the team and other management teams to ensure business objectives are aligned and that the company is performing to operational objectives.
- Coach, mentor and lead highly dynamic team members to help achieve the requirements of this position as well as the individual career goals of team members. Develop and champion an organizational culture that promotes behaviours that lead to superior business performance and organisational excellence.
- Ensure that the company’s product quality and reliability meets or exceeds customer’s expectations. Creates an organizational commitment to customer service.
Key Responsibilities
- Lead the company’s quality assurance program to provide appropriate oversight of and commercial & clinical manufacturing activities.
- Liaise with R&D QA in relation to pre-clinical, clinical, pharmacovigilance operations as they pertain to commercial affiliates
- Work with VP R&D QA to ensure that the appropriate level of service is provided in relation to the management of the QA systems. Develop and maintain a service level agreement to codify the QA systems service to R&D.
- Develop and execute quality by design and quality assurance strategy for new product development.
- Develop quality assurance plans and systems to ensure commercial manufacturing, process development programs and commercial affiliates remain compliant with all applicable regulations and guidelines.
- Keep abreast of competitive quality control and assurance practices and utilize this knowledge during on-going development and adjustment of company plans.
- Support Regulatory Affairs to develop and maintain strong internal and external relationships with regulatory bodies and authorities.
- Effectively create and champion quality process enhancement initiatives to maintain an environment of continuous improvement throughout the organization
- Develop, implement, manage and oversee GXP quality systems to support commercial manufacturing, process development and commercial affiliate activities across the entire company.
- Ensure an effective and compliant vendor qualification program is in place for suppliers
- Ensure that cGMP requirements, quality standards and policies are recognised, understood and maintained across the company
- Analyses regulatory authorities’ programmes and activities in areas relevant to bio/pharmaceutical products and advises management of potential and actual actions that could adversely affect the business, present quality exposures, or represent opportunities to be pursued.
- Ensures a GXP compliant documentation control system is maintained by managing the Global Quality Management system and associated employees.
- Work across all disciplines to ensure that the company maintains a state of readiness for GMP inspections by regulatory agencies. Ensures all employees comply with all applicable company and governmental (EPA, OSHA, FDA, etc.) regulations, policies and guidelines.
- Provide oversight for Quality Control activities performed by contract testing labs and contract manufacturing companies.
- Achieve financial objectives by preparing the quality assurance budget, scheduling expenditures; analysing variances and initiating corrective actions
- Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participating in professional societies.
- Travels to locations in order to facilitate/coordinate activities, resolve issues, etc.
Person Spec
- BSc in life sciences. MSc or PhD preferred.
- 15+ years in pharmaceutical industry, including a minimum of 10 years in a senior leadership position within the bio/pharmaceutical industry
- Experience in strategic planning and collaboration with executive and key operational groups
- Progressive and proven track record of leadership and managing quality with global responsibility across multiple functions
- Extensive experience in cGXP and other regulatory compliance requirements
- Excellent organizational, verbal, communication and presentation skills
- Ability to effectively lead and participate on multi-disciplinary teams
- Ability to work independently with minimal direction
- Ability to develop and manage a high-performance team focused on accountability and meeting/exceeding expectations.
- Ability to lead, influence, create and work within a multi-functional environment
- Assertive, proven manager with a strong results orientation and sense of urgency
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and pharmaceuticals. Ability to apply cGXP regulations and other FDA and international guidelines to all aspects of the position. Proven success in managing in a global organization
Key Competencies Required
- Leading the Organization: Develops/communicates a compelling vision and sense of purpose for the function/organization; works collaboratively to formulate long-range and mid-term strategies; demonstrates courage in advancing new, innovative ideas; champions change initiatives to enhance organizational performance.
- Collaboration: Works with others and builds effective relationships to accomplish common goals and objectives. Shares information, ideas and solutions with others. Recognises when compromise is necessary while working towards consensus with a focus on outcomes which reflect the collective need.
- Influence and Impact: Develops effective influence strategies based on an understanding of the motivations and needs of others; effectively represents one’s own perspective and communicates in a manner that generates support and commitment for proposals/recommendations to enhance the organization’s performance.
- Integrity: Displays honesty, truthfulness, trustworthy, principled actions and leadership, business ethics and compliance. Demonstrates consistency between words and actions. Direct and honest in communication and feedback. Honours commitments to others. Handles confidential and sensitive information appropriately.
- Pursuit of Excellence: Continually improves and adds value. Is committed to high quality and standards. Is proactive in addressing issues that might cause problems or processes needing improvement.
- Innovation: Approaches problems with curiosity and open-mindedness. Takes educated risks. Is willing to explore new ideas and methods. Is willing to embrace and lead change. Is passionate about quality.
- Leadership responsibilities are fulfilled through:
- Excellent interpersonal skills
- Quality management skills: problem solving, statistical thinking, design of experiments, etc.
- Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people’s energy, manages team members.
- Superior time management skills
- Attention to detail without losing sight of the big picture
- Keeps up to date with technical and managerial developments in the industry
- Adaptability and flexibility.
- Ability to travel globally up to 30%, as needed.
Cv to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie