Senior QA Manager
Grand Rapids, MI
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: Senior QA Manager
Location: Grand Rapids, Michigan
Hours: 1st Shift
Employment Type: Permanent
Provides direction and leadership to the client's Quality Systems with oversight of the Quality Assurance Functions: Operations, including Aseptic Manufacturing (formulation and filling) and Finishing (inspection, labeling and packaging) operations, and Client and Project Support.
This position works closely with all levels of the Operations (Manufacturing and Finishing), Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business Development and Finance teams.
- Provide leadership to Quality Assurance Managers/Supervisors and high-level Specialists.
- Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring.
- Ensure Quality Assurance support and oversight of all of clients Operations across all shifts, including occasional weekend support.
- Ensure Quality Assurance support and oversight of project work, including tech. transfer / client based projects; including documentation in support 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.
- Candidate must have a minimum Bachelor s degree in scientific discipline
- 10-12 years of work experience in a related field
- Aseptic experience or sterile fill or sterile finish is a must
- At least 5 years of prior management / leadership experience required.
- Prior experience interacting with regulatory authorities is 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.
- 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 individual 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
Search words: Investigations, cGMP, QA, Quality Assurance, pharmaceuticals, manufacturing, compliance, samples, finished products, batch records, documents, aseptic, sterile, Parenteral drugs