Provides direction and leadership to the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of the Quality Assurance Functions, supporting Operations at the Front, Godfrey and Patterson facilities, including Aseptic Manufacturing (formulation and filling), Finishing (inspection, labeling and packaging) and Incoming Material operations. This position works closely with all levels of the Operations (Manufacturing, Finishing, Warehouse), Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business Development and Finance teams.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Provide leadership to Quality Assurance Managers/Supervisors, QA Specialists and QA Technicians. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring.
- Ensure Quality Assurance support and oversight of the above GRAMs Operations across all shifts, including weekend support.
- Ensure Quality Assurance support and oversight of continuous improvement projects.
- Review, assessment and approval of non-conformance reports, including deviations, laboratory / OOS investigations and environmental investigations.
- Oversight and management of Material and Batch Review / Release, Non-Conformance and Corrective / Preventive Action (CAPA) systems.
- Client support / interaction related to these processes.
- Interface with auditors, including client representatives and regulatory agencies.
- Perform Quality Assurance review and approval of cGMP
- 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.
DESIRED SKILLS & ABILITIES
- 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.
- Ability to manage and lead multiple teams to achieve common goals.
- 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.
Qualified candidates have at least 5 years of prior management / leadership experience. Prior experience interacting with regulatory authorities is preferred. The level of knowledge required to successfully perform these duties is normally acquired through completion of a Bachelor's Degree in Life Sciences or a related field and/or a minimum of 10-12+ years related work experience.
GRAM supports Equal Opportunity Employment