External Manager of Quality Assurance

Job Summary

As the External Manager Quality Assurance Manager for Sterile Ophthalmic Products, you will play a pivotal role in ensuring the quality and compliance of our contract manufacturing processes and products. Your primary responsibility will be to lead and manage the Quality Assurance team, implementing and maintaining quality systems that meet regulatory requirements for sterile pharmaceuticals.

In addition to their primary responsibilities, the QA Manager also offers essential administrative assistance to the internal quality department. This multifaceted position involves handling administrative tasks and projects for both the management and other members of the quality department, contributing to the overall efficiency and effectiveness of the team's operations.

Decision-Making Authority:

• Approve or reject deviations, CAPAs, change controls, and quality agreements.
• Provide the final decision on batch disposition (release or reject).
• Approve master batch records and raw material specifications.
• Define GMP-related strategies and positions in collaboration with key stakeholders.

Essential Responsibilities

Team Leadership:

• Supervise and lead the QA team, providing guidance, training, and support to ensure a high level of performance and compliance.
• Foster a culture of continuous improvement, accountability, and proactive problem-solving within the QA team.

Quality Systems Management:

• Develop, implement, and maintain robust quality systems in collaboration with our Contract Manufacturing Organization (CMO) partners, ensuring compliance with regulatory requirements, including but not limited to cGMP, FDA, and other relevant guidelines.
• Conduct joint internal audits with CMOs and oversee external audits to assess compliance with quality standards.

Regulatory Compliance:

• Work closely with our Contract Manufacturing Organization (CMO) partners to stay abreast of changes in regulatory requirements related to sterile ophthalmic products, ensuring joint compliance efforts.
• Interface with regulatory agencies during inspections and provide necessary documentation and support

Record Review:

• Collaborate with CMOs to oversee the joint review and approval of batch records, protocols and APQR, ensuring accuracy, completeness, and compliance with established procedures.

CAPA Management:

• Manage and provide Approval of deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA) as needed.

Change Control:

• Work collaboratively with CMOs to manage the change control process for sterile ophthalmic products, assessing the impact on quality systems and ensuring joint documentation and approvals.

Vendor Management:

• Collaborate with the procurement team to assess and manage the quality of materials and services provided by external vendors and contract manufacturing organizations (CMOs).

Other duties:

• Engage in various Quality and compliance projects as delegated by the management.
• Fulfill other duties as assigned.

Qualifications

• A minimum of BS/BA in a scientific discipline.
• 6 years related industry experience with a minimum of 2 years’ management experience in quality assurance, quality control and compli
• Strong organizational skills, including ability to follow assignments through to completion.
• Knowledge of relevant regulations and guidance documents
• Strong decision-making capability and ability to ask compelling questions and to think strategically and understand the global impact of decision.
• Excellent verbal and written communication skills
• Detail-oriented with skills in problem solving and solid decision-making abilities.
• Experience with working autonomously with proven ability to meet deadlines.
• Experience with full life cycle project management (initiation, planning and design, and executing)
• Experience working with Contract Manufacturing Organizations (CMOs) preferred.
• Proficient in the use of standard Microsoft Office software products, including Outlook, Word, and Excel required.