At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of laboratory testing and consulting services; dedicated to the mission of helping the best companies in the world improve the quality of life by providing the highest standard in laboratory testing.
Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays and PTO, and the opportunity to attend many company-sponsored employee and family events.
Safeguarding Global Health. It's what we do!
The Senior Quality Assurance Manager provides QA and regulatory direction and business oversight across their business location and QA team(s) while managing day-to-day QA and regulatory operations amongst their team(s). They are accountable for execution of QA and regulatory processes relative to the business location, including complaints, corrective and preventive actions, change management, internal audits, external audits, supplier management, management review, and quality agreements. They are responsible for ensuring the business location's compliance with applicable regulations and ISO standards.
The Senior Quality Assurance Manager is the deputy for the Director of Quality Assurance (North America). They work closely with the Director of Quality Assurance ensuring regulatory, policy, and procedural compliance across their business location. They are a QA subject matter expert and technical resource for QA staff and internal teams. Given their expertise, they may be required to support the Director of Quality Assurance with QA and regulatory operations across multiple locations (where needed).
The Senior Quality Assurance Manager assists with day-to-day quality team operations and may be required to provide oversight of one or more of the quality audit team members, including supervision of team members. They lead and develop others to increase the company's leadership bench. Additionally, they are accountable to ensure the training needs of their team are addressed.
Education and experience requirements:
B.A./B.S. (microbiology, biology, pharmaceuticals or chemistry strongly preferred) or applicable quality/regulatory degree.
Five years applicable quality experience with demonstrated proficiency for management, supervision, and quality/regulatory expertise.
- Execute the Nelson Labs' business unit strategy and ensure alignment with our One Company values, mission, and goals.
- Ensure company-wide communications are understood by the appropriate personnel.
- During mergers or acquisitions, provide support to Director/Senior Director of North America Quality to help as needed with integration.
- Coordinate cross-functional efforts with internal departments across varying geographies.
- Establish and monitor lab section specialization for their QA team members as needed
- Establish and monitor operational metrics and KPIs for their QA team(s) as needed
- Manage operations of QA team(s) within established budget
- Oversee business location management review and quality metrics
- Oversee the continuous improvement process efforts of their business location
- Train, supervise, and mentor their QA team
- Lead quality team meetings, when appropriate
- Review SOPs in MasterControl
- Review protocols, raw data, validations, or final reports as needed
- Perform Internal Audits as needed/requested by the Internal Audit Coordinator
- Lead compliance projects as needed
- Perform other duties as assigned.
Department Management (as assigned)
- Align department goals and objectives with the NLI goals and objectives.
- Manage workflow and ensure department resources and personnel are adequate
- Develop and implement process improvements to increase efficiencies and reduce waste
- Manage personnel issues and provide timely feedback/reinforcement on performance
- Ensure adequate cross-training within the department to effectively manage changes in workflow
- Ensure personnel receive adequate communication and direction to perform their job functions
- Ensure company-wide communications are disseminated to the appropriate personnel
- Ensure the NLI service standard is known and practiced within the department
- Ensure personnel know and follow company policies and procedures
- Take counseling and disciplinary actions when appropriate
- Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
- Know and follow company policies and procedures.
- Complete required training on time.
Regulatory & Compliance Oversight
- Ensure personnel know and follow applicable regulatory requirements (GMP, GLP, ISO, etc)
- Implement quality process improvements to meet regulatory and client requirements
- Participate in regulatory audits as needed
- Teach technical training sessions as assigned by the Professional Development Department
- Attend seminars to keep current with technical literature and transfer knowledge to staff
- Ensure all individuals supervised receive appropriate regulatory training
- Lead or assist in client and regulatory audits as necessary
- Submit written reports to management as needed
- Serve on the management review team/ quality committee
- Review and approve company SOPs and validations
- Perform all duties outlined in the quality manual and other SOPs
- Attend work regularly and reliably
- Adhere to all policies and procedures
- Perform other duties as assigned
Competencies of this position
- Be a change advocate
- Attention to detail
- Project management
- Proficient verbal & written communication skills
- Ability to work independently
- Decision making/problem solving creating win/win situations
- Time management- response time, meeting deadlines
- Excellent customer service/interpersonal skills
- Conflict management- diffusing situation and creating win/win situations
- Follow instructions/assist others in following instructions
- Presentation skills/public speaking for dashboards
- Basic computer skills
- Knowledge and application of GMP, GLP, and ISO 17025 requirements
- Ability to establish strong KPIs to drive operational performance and efficiencies
- Ability to apply regulations in a valuable way to the companY
- Proficient in Microsoft programs and typing.
- Ability to prioritize tasks from a risk-based approach and consistently meet deadlines
- Ability to communicate internally and externally in a clear and objective manner
- Solution driven
- Excellent response times and service for our clients and potential clients
- Ability to quickly adapt to change
- Effectively work with and support other members of management
- Effectively supervise and delegate assignments to staff members
- Be proactive in continuous improvement of systems, processes, and procedures
- Successfully lead and implement company initiatives
- Demonstrated knowledge of trend analysis to identify and act on recurring issues
This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors and file cabinets.
Occasional travel during the business day. Some out-of-the area and overnight travel may be expected. May be required to attend trade shows, seminars and conferences in addition to sales travel.
Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the computer. Must be able to occasionally lift a maximum of 45lbs.