Senior Manager, Quality Assurance (Gmp Operations)

Position: Senior Manager, Quality Assurance (GMP Operations) Location: Boston, MA

Job Id: D028-R # of Openings: 1

Ensoma is seeking an experienced GMP Quality Assurance professional to use your resourceful and innovative thinking for a highly visible role within our rapidly growing company. In this role, you will be responsible for establishing and maintaining global standards for Good Manufacturing Practices (GMP), ICH, FDA, and EMA regulations. You will use your experience in building and maintaining trusting relationships with key strategic internal and external partners, including the ability to help grow the Quality function to support development programs from preclinical through clinical phases.

We are looking for an individual that thrives working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Your excellent interpersonal skills and tested conflict management and negotiation skills will be key as Ensoma shifts to a Development-stage company. We are seeking someone with a demonstrated ability to translate strategy into action, excellent analytical skills, an ability to communicate complex issues clearly to a broad group of people and experience orchestrating plans to resolve issues and mitigate risks.

Responsibilities:

• Manage relationships with outsourced GMP operations at various Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Labs (CTLs)

• Develop and maintain quality questionnaires and quality agreements

• Review and approve documentation generated at CDMOs and CTLs, including master batch records, specifications, protocols, and reports

• Review and approve product specifications, certificates of analysis, and stability protocols/reports

• Conduct final batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigations

• Provide input during the review and approval of internal Standard Operations Procedures (SOPs) in compliance with applicable regulatory requirements

• Help to build the internal quality management system, including the development of vendor management and batch disposition processes

• Conduct and/or manage internal and external audits to ensure compliance to all relevant policies and procedures as required

• Represent Quality Assurance on project teams, as needed

• Provide Quality Assurance input and/or review during the submission of regulatory filings

• Recruit, train and mentor direct reports

Qualifications:

Required:

• A Bachelor's Degree in life sciences, pharmacy, or related discipline, with a minimum of eight years of experience in Quality Assurance with demonstrated leadership skills, including at least five years of experience working in GMP product development, manufacturing, and testing

• Proficiency with interpreting and implementing GxPs, FDA, EMA, PMDA, ISO and ICH Regulations and guidelines

• Experience independently conducting and leading GMP audits

• Demonstrated knowledge of Quality Systems and GxP within an FDA-regulated environment

• Proven track record of success with anticipation and prevention of long-range problem solving

• Ability to work collaboratively across departments, within a multi-disciplinary team, as well as with external partners and vendors

• Travel to domestic or international partner sites up to 10% of the time, as required

Preferred:

• Advanced Life Sciences degree and/or MBA

• Experience with Preclinical to Phase 2 stage product development with Gene and Cell Therapy products

• Experience in reviewing submission documentation

• Prior experience in participating in regulatory inspections

About Ensoma:

Ensoma is a place where you can ask the big questions. We look at gene therapy today and ask: What if we could eliminate the patient burden? What if we could treat diseases that affect millions? What if we could treat people anywhere around the world?

Ensoma was founded to answer these questions through our Engenious platform that can transform the hematopoietic (blood & immune) system with a single treatment. Our Engenious gene therapy platform is the first to precisely engineer any or all hematopoietic and immune cells with a one-time, off-the-shelf in vivo treatment. Engenious therapies have an unmatched capacity to deliver all modern genetic modification tools and set a new standard for versatile cell programming and control across a range of complex diseases. We believe the future of medicine lies within us - and this bigger, bolder vision for gene therapy needs incredible people to make it a reality.

For our team, realizing this vision is personal. Founded and guided by leaders drawn from the top of the cell and gene therapy field, we feel an urgency and passion for our work driven by its potential global impact.

A meeting at Ensoma is a space where curiosity, trust, authenticity, problem-solving and professional development are celebrated. A career at Ensoma is an opportunity to be part of the team building the future of medicine.

Ensoma is a 5AM Portfolio company supported by top-tier investors, strategic partners, and a passionate team committed to a bold global vision for genomic medicines. Ensoma is headquartered in Boston, Massachusetts and has operations in Copenhagen, Demark. For more information, please visit www.ensoma.com.