Overview
We are seeking an experienced and motivated Validation leader to develop and lead a validation team, manage client relationships, and support business growth. The ideal candidate will have a strong background in validation services within the pharmaceutical, biotechnology, or medical device industries, with proven leadership skills and the ability to drive customer satisfaction and operational excellence. This role will involve team leadership, business development, and managing key client engagements to ensure compliance with regulatory standards.
Responsibilities
Team Leadership & Development:
* Lead, mentor, and develop a team of validation engineers and specialists.
* Oversee daily operations, ensuring project deadlines and quality standards are met.
* Foster a culture of continuous improvement and professional development.
* Ensure team compliance with industry standards, regulations, and best practices (e.g., FDA, GMP, GxP, ISO).
Business Development:
* Identify and pursue new business opportunities within the pharmaceutical, biotech, and medical device sectors.
* Collaborate with senior management to develop and implement strategies for company growth.
* Lead or assist in the preparation of proposals, quotes, and contract negotiations.
* Maintain awareness of industry trends and emerging validation needs to shape service offerings.
Customer Relationship Management:
* Serve as the primary point of contact for key clients, ensuring a high level of satisfaction.
* Establish strong client relationships through regular communication, updates, and feedback sessions.
* Manage project scopes, timelines, and budgets in alignment with client expectations.
* Provide technical expertise and support to clients, ensuring all validation activities meet regulatory requirements.
Additional Competencies:
* Experience managing multi-disciplinary teams across multiple projects.
* Ability to build and maintain strong working relationships both internally and externally.
* Familiarity with risk management, quality systems, and compliance requirements.
* Ability to adapt to a fast-paced, dynamic work environment.
Qualifications
* Bachelor’s degree in Engineering, Life Sciences, or related field.
* Minimum of 5-7 years of experience in validation roles within the pharmaceutical, biotech, or medical device industries.
* Strong leadership and team management skills.
* Proven experience in client relationship management and business development.
* Excellent communication, organizational, and problem-solving skills.
* Knowledge of regulatory requirements and validation processes (e.g., equipment, process, cleaning, computer systems validation).
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