Position: Senior Quality Manager
Status: Exempt, salary
Department: Quality Assurance
Reports to: Vice President of Quality Assurance
Job Summary: Reporting directly to the Vice President of Quality Assurance, this position will be responsible for daily oversight of Quality Assurance functions (QA inspections, Document Control, Change, etc.)
Duties and Responsibilities:
- Oversees compliance to internal procedures, policies and standards, as well as all relevant State, Federal and International regulations.
- Provides technical expertise in the manufacturing, packaging, and testing activities associated with the manufacturing of solid dose and liquid drug products.
- Revises departmental procedures (SOPs) as necessary to ensure compliance to regulatory standards and company policy.
- Maintains a working knowledge of government and industry quality assurance codes and standards.
- Assists in the training of employees on GMP.
- Other duties as assigned
Education and/or Experience:
- Bachelor of Science degree (science or engineering preferred) or Advanced degree in Business or Engineering
- Minimum of 10 years of experience in managing and improving Quality systems
- Experience hosting or assisting during customer or regulator agency inspections.
- Extensive audit experience for API, excipient, and components used in the pharmaceutical industry. Auditor certification, for example ASQ Certified Quality Auditor, preferred.
- Detail oriented with well-developed organizational skills
- Must be “flexible” and capable of adapting to changes that occur due to changing business needs
- Able to effectively verbally communicate to multiple level personnel and departments within the company
- Must have the ability to relate to and work well with individuals and a diverse workforce in a “team” focused environment
- Able to handle multiple tasks and make quick sound decisions
- Working knowledge of business software packages, such as Word, Excel, and Access, and modern office equipment
- Physical activities include, but are not limited to, repetitive motions. Substantial movements (motions) of the wrists, hands, and/or fingers.
- The physical requirement is sedentary. Exerting up to 10 lbs. of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Sedentary works involves sitting most of the time. Walking and standing are required only occasionally.
- The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
- The employee is not substantially exposed to adverse environmental conditions.