Director, CMC QA

About the role

The Director, CMC QA will lead the quality assurance efforts for chemical manufacturing and control processes within the R&D department. This role requires strong leadership skills, expertise in quality management systems, and experience in pharmaceutical or biotech industries.

Responsibilities

• Oversee the implementation and maintenance of quality management systems for CMC processes.
• Develop and enforce quality standards and protocols for all CMC activities.
• Conduct regular audits and assessments to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to identify and mitigate risks associated with CMC processes.
• Ensure continuous improvement through the implementation of new technologies and methodologies.

Requirements

• Bachelor’s degree in a relevant field (e.g., chemistry, engineering, or life sciences).
• At least 10 years of experience in quality assurance or related roles in the pharmaceutical or biotech industry.
• Proven track record of leading quality initiatives and driving process improvements.
• Experience with regulatory guidelines such as FDA cGMP and EudraLex.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.

Qualifications

• Knowledge of Good Manufacturing Practices (GMP) and GCP.
• Experience with quality system documentation and auditing.
• Ability to work independently and manage multiple projects simultaneously.
• Fluency in English.

Skills

• Leadership and strategic planning skills.
• Technical proficiency in relevant software and tools.
• Ability to communicate effectively with cross-functional teams.
• Strong attention to detail and organizational skills.

Benefits

• Competitive salary commensurate with experience.
• Flexible work schedule with hybrid options.
• Health insurance coverage.
• Employee discounts on company products/services.
• Professional development opportunities.

Pay

Commensurate with experience.

Schedule

Hybrid.