What are the responsibilities and job description for the Director of Quality Assurance position at Reed-Lane?
Job Summary
The Director of Quality Assurance plays a crucial role in maintaining the integrity of our products while ensuring compliance with industry standards. This position is ideal for a proactive leader who is passionate about driving quality excellence within an organization.
Administrates and assures operational compliance to cGMP’s as well as Reed-Lane SOP’s and customer required protocols in accordance with CFR Title 21, Part 11, 210 & 211 as well as ICH and EU Guidelines. Direct all Quality Assurance personnel in the execution of their responsibilities.
Responsibilities
- Provides leadership, guidance and direction to direct reports and the Quality Assurance team in support of achieving individual goals, goals of the department, and goals of the Reed-Lane organization.
- Ensure Quality Systems and procedures governing the handling of products and components for packaging at Reed-Lane in place.
- Provides Quality oversight and guidance of activities to ensure that all products are packaged in accordance with customer specifications and internal GMP/SOP requirements.
- Provides representation and communication during audits with Customer Quality Units and Regulatory Agencies.
- Review and approval of SOP’s, Investigations, Deviations, Complaints, Validation Protocol, Master Packaging Orders and other quality system records as required by SOPs.
- Assures that all deviations, non-conformances and customer complaints are appropriately investigated and assures that necessary Corrective and Preventive actions are documented, implemented and deemed effective.
- Review and Approval of Reed-Lane and Customer Annual Product Reviews.
- Supports development projects by performing due diligence/evaluation audits of potential partners for Reed-Lane, including performing GMP audits
- Works in partnership with customer’s Quality and Regulatory Affairs
- Ensures that the necessary documents are available and provided for regulatory applications.
- Negotiate and implement Quality Agreements.
- Oversees Internal and External Audits
- Manage all required State and Federal Registrations.
- Manages DEA requirements, prepares and submits quarterly ARCOS reporting.
Qualifications
- BA in an affiliated Science and minimum 5 years Quality Assurance Management experience.
- Proficient knowledge of GMP, CFR Title 21 Parts 11, 210 211 as well as EU and ICH Guidelines.
- Proficient knowledge of Pharmaceutical manufacturing, packaging as well as component and product testing.
- Experience conducting quality audits and implementing corrective actions.
- Exceptional analytical skills with attention to detail.
- Strong leadership abilities to manage a diverse team effectively.
- Excellent communication skills for interacting with stakeholders at all levels.
Job Type: Full-time
Pay: $140,000.00 - $160,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Retirement plan
Schedule:
- 8 hour shift
- Monday to Friday
Education:
- Bachelor's (Required)
Work Location: In person
Salary : $140,000 - $160,000