Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

1. Acts as a key contributor to the overall quality direction of the company. Communicates and works together with other management at sister company to maintain and improve the direction of the company.
2. Develops and implements the quality assurance and quality control programs at sister company to ensure conformity of processes to established quality standards.
3. Maintains a high level of understanding of relevant production processes and quality systems related to 21 CFR 210/211 and Part 820 (applicable sections for combination products).
4. Reports to management on the performance of the QMS and the avenues for improvement.
5. Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Change Requests, Batch Records and associated documentation, Product and Component Release, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, Standard Operating Procedures
6. Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
7. Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives.
8. Facilitates process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices.
9. Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders.
10. Oversees Supplier Management, including but not limited to, Annual Assessments, Quality Assurance Agreements, and KPI’s.
11. Collaborates in data analysis and report creation on quality metrics and key performance indicators.
12. Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance are crucial for efficient plant operations, safety, and morale.

SECONDARY DUTIES AND RESPONSIBILITIES

1. Strong collaboration with the other regional and global sites to ensure consistent application of quality systems / processes across the site.
2. Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
3. High level of proficiency in problem-solving, creativity, independent thought, and sound judgment.
4. Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
5. Training and mentoring of other members of the organization.
6. Strong performance history of consistently meeting and exceeding expectations.
7. Other duties and responsibilities may be assigned as required.

Experience and Skills:

QUALIFICATIONS

1. Bachelor’s degree in a science/technical field such as Pharmacy, Biology, Chemistry, or Engineering or any bachelor’s degree with three years of experience in pharmaceutical industry in roles covered by GMP oversight.
2. Excellent oral and written communications skills.
3. Strong ability and motivation to learn.
4. Minimum of five years of experience in the pharmaceutical industry and/or FDA experience with at least a minimum of three years of experience in Quality Assurance/Compliance.
5. Preferred minimum of seven years of experience in QA/Regulatory Compliance in the p pharmaceutical industry.
6. Strong knowledge of global regulatory and cGMP requirements, industry best-practices.
7. Strong familiarity with production operations.
8. Strong leadership, project management, and technical writing.
9. Strong interpersonal, communication, and influencing skills.

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