QA Manager

JOB SUMMARY

Our client, a contract manufacturer of Animal Health FDA and EPA regulated products, is seeking an experienced individual to lead the Quality Assurance Department. This position will require an extremely efficient, dynamic, agile and hands-on individual interested in building relationships with customers and vendors to ensure the production of quality products. The individual will provide day-to-day management of the Quality Assurance functions including: oversight of QA; work with functional groups to provide direction and appropriate solutions for compliant operational practices; drive decision making and issue resolution on QA and advise management on areas of regulatory / business risks related to quality assurance activities.

ESSENTIAL FUNCTIONS:

• Responsible for the design and implementation of policies and procedures to ensure that quality standards are met during production.

• Ensure all aspects of handling, manufacturing and distribution of products comply with contract manufacturing agreements and meet relevant cGMP, regulatory and legislative requirements.

• Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.

• Responsible for operational compliance of bulk and fill finish product manufacturing including: batch record review, batch release, deviation investigations and shop-floor quality groups.

• Oversee the evaluation of finished products for quality and reliability.

• Maintain current knowledge of regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on quality matters is provided to the company.

• Leads coordination and preparation of activities related to regulatory agency inspections.

• Ensure that the quality department operates in a cost effective and efficient manner and maintains an innovative approach based on productivity improvement, implementation of best practice and harmonization with Operations Department.

• Provide leadership, direction and support to the people within the department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties.

• Leads and coordinates the qualification and auditing of vendors and subcontractors.

• Has accountability for the company’s document control system and related processes.

• Establishes and oversees the internal quality systems and policies throughout the company including all activities related to GMP, SOPs and training.

The above statements are intended to describe the general nature and level of work being performed by employees in this position. This is not intended to be an exhaustive list of all responsibilities.

EXPERIENCE:

• At least 5 years’ experience in the pharmaceutical industry with a minimum of 3 years in a Quality Assurance, Quality Control or Regulatory Compliance role.

• Requires current and strong working knowledge of GMP and FDA (CFR 211, CFR 225, CFR 226).

• Experience with EPA regulated products a plus.

• Experience in developing, tracking and reporting KPI's and manufacturing metrics.

EDUCATION / TECHNOLOGY SKILLS:

• Requires a Bachelor’s or Master’s degree in a scientific discipline.

• Professional certification in quality, compliance or regulatory affairs a plus.

• Proficiency with MS Office, quality system databases and electronic document management.