Manager, Quality Operations (no agencies please)

Convergent Therapeutics, Inc.; Boston (MA); On-site; USD 122,000 - 150,000; Full time

Job summary

A clinical-stage radiopharmaceutical company is looking for a Manager of Quality Operations to oversee quality assurance systems and support the CMC activities. The role requires at least 5 years of quality assurance experience in the pharmaceutical industry and expertise in GMP regulations. The candidate should have excellent communication and interpersonal skills, a strong track record in managing quality systems, and the ability to work in a fast-paced environment. This mid-senior level position offers a full-time role with travel of up to 15%.

Qualifications

• 5+ years of experience in quality assurance within the pharmaceutical industry.
• Experience in new therapeutic modality manufacturing and clinical trial supplies.
• Proven track record managing GMP-compliant quality systems.

Responsibilities

• Oversee the development of batch records, validation protocols.
• Interact with manufacturing and operations to ensure quality.
• Support vendor qualification and monitor vendor performance.

Skills

GMP regulations

Interpersonal skills

Problem-solving

Communication skills

Critical thinking

Education

Advanced degree in chemistry, biochemistry, radiochemistry, or related field

Job description

Manager, Quality Operations (no agencies please)

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Convergent Therapeutics is seeking a Manager of Quality Operations to support critical CMC activities for our growing clinical‑stage radiopharmaceutical product. This person will be responsible for overseeing the build and deployment of internal quality assurance systems in support of CMC as well as providing quality oversight of all external manufacturing operations for drug substance and drug product.

As a start‑up organization, we value team members eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi‑tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Responsibilities

• Review and approve specifications affecting product quality and oversee the development of batch records, validation protocols
• Oversee the quality operations for drug substance, drug product, packaging/labeling, and third‑party logistics vendors
• Interact with manufacturing, clinical, operations or other functional areas as they impact quality operations and ensure cross‑functional completion of issues or actions identified
• Review change controls, deviations, investigations, OOS, CAPA, and product quality complaints
• Assist in risk assessment and implement appropriate quality and process controls to ensure proper oversight of all production activities
• Support vendor qualification program, review written reports, follow up to resolve findings, and monitor vendor performance
• Prompt communication to management of critical and/or compliance issues
• Participate in quality management meetings such as MRB, QMR, etc.
• Review process and method development/qualification/validation protocols and reports as needed
• Assist in updating CMC sections of regulatory and quality documents
• Participate in the site inspection readiness program
• Support internal audit program that is focused on prevention versus correction
• Participate in continuous improvement initiatives to accomplish compliance, productivity, cost‑effectiveness, and enhanced efficiencies of processes and procedures as they pertain to quality

Requirements

• Advanced degree in chemistry, biochemistry, radiochemistry, or related field is preferred.
• 5+ years of progressively responsible experience in quality assurance within the pharmaceutical industry
• Experience in new therapeutic modality manufacturing and development, packaging/labeling, third‑party logistics, and supporting continuous clinical trial drug product supplies. Commercial manufacturing experience is a plus.
• Demonstrated track record in effectively managing GMP‑compliant quality systems
• Knowledge of GMP regulations
• Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals
• Excellent verbal and written communication skills
• Ability to think critically and take a collaborative approach to problem‑solving
• Ability to work effectively in a regulated and fast‑paced environment
• Demonstrates a high level of professional integrity and trustworthiness with strong work ethics
• The candidate must reside in the Greater Boston area.
• Position requires up to 15% travel.

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Management and Manufacturing

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Location and Salary

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