Job Description
Latham BioPharm Group, Inc. is seeking an experienced professional to lead the EU Quality Assurance (QA) group. The successful candidate will be responsible for establishing and managing compliance activities across multiple GXP areas. This role will involve coordinating with vendors, internal stakeholders, and external parties to ensure adherence to regulatory requirements.
The ideal candidate will have a minimum of 15 years of experience in QA and compliance, with a proven track record of leading and coordinating compliance activities through various stages of development. Strong management, organization, and leadership skills are essential, as well as the ability to work independently and adapt to a fast-paced environment with changing priorities.
Responsibilities will include:
* Creating robust compliance strategies in each GXP area
* Maintaining quality management systems for clients
* Developing and maintaining SOPs and other documentation to support GXP compliance
* Ensuring clients have appropriate documentation or systems in place to maintain compliance
* Conducting audits of internal and external parties as required for GXP compliance
* Performing due diligence assessments for external parties
* Building and managing the QA department at the EU location
* Assisting clients in managing compliance
* Reporting on compliance activities and corrective actions to client leadership teams
Qualifications
Education: Bachelor's degree in a relevant scientific or engineering field.
Experience:
* Minimum of 5 years prior consulting experience
* Travel up to 30%
* Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with a focus on product development and regulatory affairs
Key skills include:
* In-depth working knowledge of cGXP and global regulatory requirements
* Effective communication and interpersonal skills
* Leadership skills and ability to work independently
* Attention to detail and flexibility
Additional Information
You can expect a supportive atmosphere that encourages innovation and initiative, a commitment to diversity and employee well-being, opportunities for personal and professional growth, and a competitive salary and benefits package.