Director of Quality

• Full-time, permanent position
• Gulfport, Mississippi, USA
• Enjoy coastal living, relocation assistance is available

Are you a seasoned Quality leader? Are you looking for an opportunity to join a team of experienced professionals and work for a stable and quality-focused company?

If this sounds like you, we want to hear from you!

We’re Raise, and we’ve joined forces with our client, a world-leading manufacturer of liquid antacids. Their high volume capacity and superior quality control make them the first choice for discerning private-label brands. They offer state-of-the-art technology, unparalleled service, economic pricing, and a professional team that is dedicated to servicing over-the-counter and personal health needs.

What you’ll be doing

As the new Director of Quality, you’ll be responsible for leading the QA/QC team, developing, implementing, and maintaining a cGMP Quality system to meet the requirements of 21CFR210, 21CFR211, regulatory agencies, and customer expectations.

Responsibilities

• Establish the quality management system to describe how the firm complies CGMPs and operates to maintain a state of control
• Keep current with good industry practices, and applicable to the mission of your operation
• Audit for compliance with policies and procedures
• Report on the performance of the quality system that helps decision-making for targeted actions
• Ensure that procedures and specifications are appropriate and followed
• Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party service providers (contract manufacturers, contract laboratories, etc.)
• Ensure that appropriate manufacturing in-process controls are implemented
• Ensure in-process controls are performed during manufacturing operations and results are satisfactory
• Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications, including changes to these documents
• Review and approve/reject reprocessing and rework procedures
• Review and approve/reject production batch records and make the final decision to release a product lot into commerce
• Ensure investigation is conducted and the root cause is eliminated for production and control record errors, discrepancies, and failure to meet specifications, including quality attributes
• Review and investigate consumer complaints
• Report on product, process, and system risks
• Report on the outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure
• Have a complete and compliant procedure that describes the responsibilities
• Be an independent reviewer and approver with respect to manufacturing and process/product development units

The successful candidate will be a strong leader/manager, they are solution-oriented and have strong attention to detail. They walk the manufacturing floor and get first-hand information to stay abreast of the latest and greatest. They are committed to achieving deadlines within a fast-paced environment and focused on high-quality work/products.

The Details

This is a full-time, permanent position. You’ll enjoy the coastal life in Gulfport, Mississippi, as the city offers something for everyone. You will work Monday – Friday from the Gulfport facility. Relocation assistance is available. In addition to a base salary in the range of $100,000.00 - $120,000.00/year (commensurate with experience), you’ll also enjoy a benefits package and vacation.

Qualifications

• B.S. in Chemistry, Biology, or a related discipline
• 7 years of management experience in a pharmaceutical manufacturing setting
• Pharmaceutical experience required
• Expert knowledge of cGMP regulations including 21 CFR 210, 21 CFR 211, regulatory agencies and audits and customer expectations
• Expert knowledge and understanding of FDA policies and regulations including ANDA (Abbreviated New Drug Application) and NDA (New Drug Applications)
• Understanding of quality systems including change control, deviations and CAPAs (Corrective and Preventative Actions)
• Strong written and verbal language skills to effectively read and write SOPs (Standard Operating Procedures) and related lab reports, and communicate with personnel at all levels in the organization
• Ability to walk, stand, or sit 8 or more hours a day

Your Application

We value diversity and inclusion and encourage all qualified people to apply; however, only those selected for an interview will be contacted.

Looking for meaningful work? We can help

Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we’re a certified B Corporation and donate 10% of our profits to charity.

We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.

We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation: https://raise.jobs/accommodations/

In order to submit candidates for roles, our clients will sometimes require personal information to confirm the identity of applicants and their legal status to work. Raise will never ask you for personal or banking information unless you have been selected for a job. If you are ever unsure about the legitimacy of this or another job posting by Raise (or have any other questions), please contact us at 1 800-567-9675