Quality Assurance Consultant - Scilex Holding Company

Salary Range: $70/hour - $100/hour

The pay range for this position is expected to be between $70/hour - $100/hour 

Job Type:  Dedicated Consultant – 20-30 hours per week

About Scilex

SCILEX Holding Company is dedicated to the development and commercialization of non-opioid pain management products. We are uncompromising in our focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. The Company’s lead product under development, ZTlido™ lidocaine patch 1.8%), is a branded lidocaine patch formulation for the potential treatment of relieving the pain of postherpetic neuralgia, also referred to as after-shingles pain.

The company’s lead product ZTlido^® (lidocaine topical system) 1.8%, is a marketed prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain. Click here for ZTLido’s Important Safety Information and US Prescribing Information.

Scilex’s SP-102 (10 mg dexamethasone sodium phosphate viscous gel injection) for the treatment of Lumbar Radicular Pain has completed a Phase III clinical trial and has received Fast Track Status from the FDA. The safety and efficacy of SP-102 has not been confirmed by any regulatory agency. Currently there is no FDA approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica. 

SCILEX is committed to harnessing the power of revolutionary delivery technologies designed to provide therapies safely and effectively to those who need them the most.

Scilex Pharmaceuticals and Semnur Pharmaceuticals are wholly-owned subsidiaries of Scilex Holding Company.

WHAT WE ARE LOOKING FOR:

We are looking for an enthusiastic and talented Quality Assurance (QA) consultant  who thrive on challenge and change, who can roll up their sleeves, put on multiple hats and have a can-do attitude without a lot of oversight or instruction.

The QA consultant candidate will report to the Chief Technical Officer and support/implement Quality Management System, Quality Assurance Compliance, Quality Audits, and external/3rd party manufacturing and supply chain of commercial and/or clinical drug products. 

The candidate will support quality compliance at contract manufacturing organizations responsible for clinical product manufacturing and/or commercial product manufacturing by the current good manufacturing practices (cGMP), commercial product supplies and/or clinical trial material supplies. The successful candidate will provide support for  chemistry, manufacturing and controls (CMC) and authoring/review/approval for product development records, manufacturing batch records, analytical records, shipping records, release/disposition of batches, investigations of deviations, excursions, out of specifications during manufacturing and testing, product complaints, standard operating procedures (SOP) of CMC Quality Assurance, regulatory submissions and support during pre-approval inspections (PAI) and GMP inspections at CMO and/or CDMO .

 The ideal candidate will be a Manager/Senior Manager/Associate Director level Quality Assurance experience and expertise person from a prior Pharmaceutical or Biotech company with a strong records of accomplishments in manufacturing, quality controls, quality management system, quality assurance, quality audits, pre-approval and GMP inspections and quality assurance aspects for Commercial cGMP Manufacturing or Clinical cGMP Manufacturing of small molecule or biological products at a global CMO or CDMO.

Role and Responsibilities:

• Support, follow and maintain GMP quality management systems, policies, and SOP.
• Contribute to Quality compliance of manufactured drug substance, raw materials and drug product, labeling, package inserts, and packaging of commercial products and clinical products, and commercial product distribution and clinical trial material distributions, as required.
• Provide Quality Assurance support of Contract Manufacturing Organization or Contract Manufacturing Development Organizations (CDMOs or CMOs), Contract Laboratories, 3rd Party Logistics (3PL) providers/distributors/shippers and other vendors used for commercial or clinical product manufacturing or testing, as required.
• Contribute to review of formulation development, method development, as required.
• Support preparation/review of documents of PAI and GMP inspections at CMO and/or CDMO, as required.
• Contribute to review of MBRs and EBRs, PV, AV, PPQ, CPV and perform final product release/stability/disposition, quality control, COA, as required.
• Support investigation and resolution of product complaints with external party and that commercial or investigational product complaints are investigated to ensure compliance, as required.
• Contribute to supply chain, logistics and return product disposition/destruction with 3PL, as required.
• Support review and approval of investigation, deviations, OOSs/OOTs, Change Controls, CAPAs and any other related quality records, as required.
• Support draft/review/approval of SOP and policies related to CMC and QA, as required.
• Contribute to audit agenda/reports, product specifications, test methods, qualification/validation protocols and reports, stability protocols/reports, as required.
• Support GMP audit activities at DS and DP contract manufacturers including establishing audit schedules, conducting audits, audit report writing/review, and close out audits, as required.
• Contribute to internal and external audit program including vendor qualification and routine or for cause audits and inspection readiness at CDMO/CMO, 3PL, and Vendors.
• Support product quality documentation system, as required.

Qualifications and Education Requirements

To perform this role successfully, an incumbent must be able to perform each essential role and responsibility satisfactorily. The preferred requirements listed below are representative of the skills, knowledge,and/or abilities required for this position and may change on a need basis.

Minimum bachelor’s degree in relevant scientific discipline or equivalent.

Minimum of 10 to 15 + years of CMC/GMP Quality Assurance (GMP QA) related prior experience in injectable, transdermal, tablet, capsule, oral solution based commercial product manufacturing or clinical product manufacturing and analytical testing at Pharmaceutical or Biotechnology Companies.

Prior experience in

• Quality Management Systems, Quality Compliance, Quality Audits for commercial products and/or clinical pipelines is a must.
• FDA pre-approval inspections and GMP inspections is a must.
• Quality Compliance for Analytical Testing, Aseptic Product Manufacturing and Solid Dosage Product Manufacturing for commercial products is a must
• working with CMO, vendors, and 3PL-supply chain/distribution of commercial. products is a must.
• working with CDMO, vendors, and 3PL-supply chain/distribution of clinical products is a plus.

Knowledge of Quality Management Systems, GMP regulations, ICH Guidelines, FDA and ROW Regulations and Iso guidance.