- Mentors and provides direction to the QA Operations organization to ensure organization is complying with local and global quality standards, regulatory requirements and partner commitments.
- Develop, motivate and lead direct reports towards achieving organizational and individual goals.
- Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
- Delivery of QA support to the compliant and on-time introduction of GMP programs into manufacturing and disposition of Drug Substance/Product
- Delivery of guidance and on-the-floor support to maintain compliance of Facility with international standards and regulations for continued GMP manufacturing
New Business Growth
- Lead client due diligence and Quality audits as well as supporting regulatory inspections.
- Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
- Ensure self, and team, have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
- Continuously improve the processes specified in Standard Operating Procedures and Work Instructions operated by self and direct reports whilst still ensuring the operations meet all current regulatory requirements.
- Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC.
- Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions.
- Review and/or approve basic and technical documentation to include, but not limited to:
- Standard Operating Procedures
- Batch Production Records (completed and approval)
- Commissioning, qualification and validation protocols and reports
- Deviation Reports, Corrective Action/Preventive Action Plans and Change Controls
- QC data review and approval
- Drug Substance/Product Reports
- Client regulatory submissions
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- All other duties as assigned.
Required Skills & Abilities:
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report writing skills.
- Ability to set personal performance goals and provide input to departmental objectives.
- Develop staff to maximize contributions to the team and the company.
- Ability to multitask and easily prioritize work.
- Ability to work independently with little supervision.
- Proficient in Microsoft Excel, Word and PowerPoint.
- All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
- Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
- Lifting up to 25 pounds on occasion.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Must be willing to work flexible hours.
- Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
- Must be willing to travel occasionally, as needed.
- Attendance is mandatory.
- Master’s degree in a science-related field with 4 years of related experience, with 2 years of supervisory experience: OR
- Bachelor’s degree in a science-related field with 6 years of related experience, with 2 years of supervisory experience.
- At least 4 years of cGMP experience.
- Certified Quality Auditor
- Degree in Biology, Chemistry