Provides direction and leadership to the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of Aseptic Manufacturing (formulation and filling) operations. This position works closely with all levels of the Operations (Manufacturing and Finishing), Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.
Responsibilities and Duties
Provide leadership to Quality Specialists of various levels. Responsibilities include hiring, managing, motivating, coaching and mentoring.
Ensure Quality support and oversight of Aseptic Manufacturing operations across all shifts, including occasional weekend support.
Oversight and management of the batch record review / in-process release processes
Review, assessment and approval of non-conformance reports, including deviations, laboratory / OOS investigations and environmental investigations.
Ownership of the Corrective / Preventive Action (CAPA) system.
Client support / interaction related to these processes.
Interface with auditors, including client representatives and regulatory agencies.
Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements, including:
Master Batch Records
Risk Assessment Reports
Support Agency, customer and vendor audits as needed.
Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Perform all other tasks, projects and duties as assigned.
Bachelor’s Degree in Life Sciences or a related field
6-8+ years related work experience.
2+ years of prior management/leadership experience
Prior experience interacting with regulatory authorities (preferred)
A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required; experience and expertise in aseptic manufacturing of regulated products is preferred.
Ability to interpret and relate Quality standards for implementation and review.
Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
Ability to portray an appropriate level of integrity and professionalism at all times.
Ability to communicate effectively with management, staff, regulators and client representatives, in both written and verbal forms.
Ability to complete tasks accurately and according to established timelines.
Demonstrated management ability with a proven track record of leading teams to meet objectives.
Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
Proficiency in both written and verbal communication and presentations
Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment
Results oriented and efficient
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged
Ability to work closely with a diverse customer base (internally and externally)
Ability to work well in a cross-functional team environment
Must have proficient computer skills in Microsoft Word, Excel and Outlook
About Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing (GRAM) is a full-service parenteral contract manufacturer with a state of-the-art cleanroom and highly trained staff that moves client projects from pre-clinical trials through successful commercialization. Our experience includes formulation, filling, lyophilization, terminal sterilization, analytical and microbiological services. Our team supports our clients and their projects by working in positions such as production/manufacturing operations, quality control and assurance, regulatory compliance, microbiology, chemistry, and validation. Additionally, GRAM’s internal business is supported by administrative functions such as accounting/finance, business development, and human resources.
GRAM has a company culture wrapped around the commitment to quality. This is exemplified by an exceptional record of FDA compliance which means that our clients can expect consistency and long-term reliability. Clients also benefit from GRAM’s commitment to superior customer service by implementing a dedicated project team. At GRAM, each person is trained that all jobs are critical to the overall quality process and their responsibility is to always do the ri...ght thing.
At GRAM we're always looking for eager team members who express a drive to learn and succeed all while maintaining a desire to produce quality outcomes for themselves and our clients. Every role at GRAM has an opportunity to move the organization to superior results!