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Job Description

We are seeking an experienced Annex 1 Assessment Subject Matter Expert with a strong background in cell and gene therapy. The successful candidate will be responsible for conducting comprehensive Annex 1 assessments, identifying gaps, and developing strategies to close those gaps. This role is critical to ensuring our facility meets regulatory standards and maintains the highest levels of quality and safety.

Key Responsibilities:

Conduct thorough Annex 1 assessments to identify gaps in compliance with regulatory standards.

Develop and implement strategies to close identified gaps, ensuring alignment with industry best practices.

Support the generation and implementation of Corrective and Preventive Actions (CAPA) to address compliance issues.

Utilize assessment tools to manage and track requirements, ensuring all 450+ rows are accurately assessed and addressed.

Collaborate with cross-functional teams to ensure seamless integration of quality and compliance measures.

Provide expert guidance on contamination control strategies and quality risk management principles.

Stay current with industry trends, regulatory updates, and best practices in cell and gene therapy.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

Bachelor's or Master's degree in a relevant field (e.g., Biotechnology, Biochemistry, Pharmaceutical Sciences).

Extensive experience in cell and gene therapy, with a strong understanding and experience of Annex 1 guidelines

Experience performing Annex 1 assessment

Proven track record of conducting gap assessments and developing effective CAPA.

Excellent analytical, problem-solving, and communication skills.

Ability to work collaboratively in a fast-paced, dynamic environment.

Strong attention to detail and commitment to maintaining high standards of quality and compliance. Experience with tech transfer processes in a cell and gene therapy setting.

Certification in Quality Risk Management or related fields.

Familiarity with regulatory requirements and industry standards for cell and gene therapy.

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We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].