Senior Manager/Associate Director, Quality

JOB SUMMARY

The Senior Manager/Associate Director, Quality Assurance will be responsible for supporting the establishment and maintenance of a comprehensive quality management strategy to ensure compliance with regulatory requirements, including those set forth by the FDA and other relevant authorities. This role requires interpreting regulations, determining quality requirements, and collaborating with internal cross-functional teams and external partners to execute a quality strategy that supports overall product quality. The successful candidate will implement standards, policies, and procedures for Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) compliance, ensuring that all stakeholders are engaged and supportive of these initiatives.

RESPONSIBILITIES:

• Accountable for compliance with regulatory requirements, including FDA and other relevant authorities.
• Interpret regulations, determine quality requirements, and work closely with internal cross-functional teams and external partners to execute quality procedures to support overall product quality.
• Implement standards, policies, and procedures for GMP, GLP and GCP compliance, engaging stakeholders in the process.
• Oversee QA reviews of GMP manufacturing batch records, product release, stability testing, validation reports, pharmacology and toxicology study reports, and essential clinical study documents.
• Oversee and manage vendors supporting quality and compliance.
• Support the establishment of Orbital’s quality system, participating in qualification of contract manufacturing sites, analytical testing sites, clinical storage, and distribution depots, and overseeing vendors that support quality and compliance.
• Plan and support GMP, GLP and GCP compliance Partners cross functionally to ensure GxP compliance for all clinical development programs by providing guidance and serving as an expert in regulatory requirements.
• Audit (US and international) to determine compliance status and identify risks.
• Assess all GMP, GLP and GCP compliance risks to clinical development programs and develop risk mitigation measures.
• Work cross functionally to ensure GxP compliance with Orbital’s clinical development programs.

QUALIFICATIONS:

• B.S. or M.S. degree in a related scientific field with 6-8 years of relevant experience in the biopharmaceutical/pharmaceutical industry.
• A minimum of 5 years of combined experience in a GMP and GCP related discipline.
• Strong knowledge of cGMP, FDA, and CHMP/EU regulations.
• Proficient in risk assessment and root cause analysis tools.
• Experience in setting up a Quality Management System (QMS).
• Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
• Meticulous attention to detail, with a focus on quality, accuracy, and compliance.
• Ability to work in a fast-paced, dynamic environment and adapt to changing priorities.