MANAGER, QUALITY ASSURANCE (GMP)

SUMMARY

The Quality Assurance (QA) Manager will be responsible for assisting in the oversight of cGMP commercial, development, and non-clinical manufacturing as it relates to QA, Quality Systems, and the Supplier Qualifications Process. This key functional role will operate within a cross-functional Good Lab Practices (“GLP”)/Good Manufacturing Practices (“GMP”) QA Team and supports internal QA functions. The position will be responsible for reviewing and maintaining cGMP manufacturing documentation, interacting with manufacturing, packaging and distribution vendors, and assist in the conduct of external and internal audits. Additionally, the function is responsible for the day to day functions within QA related to supplier qualifications and auditing of all GLP/GMP service providers. The QA Manager shall provide oversight to ensure compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:

  • Manage, process and conduct investigations into product complaints and shipping incidents.
  • Manage, process and conduct CAPA, supplier qualifications, and audits of GLP/GMP service providers.
  • Participate on project teams, serving as the QA representative and escalate issues to senior QA management when appropriate.
  • Review and disposition of API, drug and finished product(s) batch records for development and commercial distribution in a timely manner.
  • Provide guidance and training to staff regarding batch review/disposition process as well as other quality processes.
  • Facilitate the change control process, and oversee and manage change controls for changes made to development, validated and commercial products.
  • Maintain tracking logs for quality systems.
  • Perform, track and report internal audit information for all areas of GLP/GMP compliance.
  • Write SOPs for the creation, development or improvement of processes related to quality systems.
  • Prepare reports for management review of key statistics such as documentation review and internal audits.
  • Other essential duties as assigned.

QUALIFICATIONS:

Knowledge of quality systems and regulatory compliance requirements within a commercial drug manufacturing operation is necessary. Experience with domestic and/or international drug development and approval process is desired.

Ability to manage the relationship between sponsor companies and contract manufacturers.

Must have attention to detail, be a critical thinker and have effective organizational skills.

Excellent communication and proficient soft skills are required.

Ability to solve problems, drive results and work collaboratively in a team environment.

Expert understanding related to GLPs and GMPs.

Travel may be required up to 25%.

EDUCATION and/or EXPERIENCE:

B.S. Degree in Chemistry, Biology, or related field, or equivalent experience.

A minimum of 8 years of experience within the pharmaceutical or biotechnology industry.

Relevant experience and knowledge of batch record review for the small molecule pharmaceutical industry is desired.

Experience with quality systems, conducting and managing internal/external audits for GMP systems, and product complaint handling is required.

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