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Manager, Quality Control

Manager, Quality Control

The Manager, Quality Control position is responsible for managing the analytical activities for commercial products outsourced to external contract manufacturing organizations (CMOs). This position leads or supports OOS investigations and other non-conforming results, implements appropriate corrective and preventative actions, and prepares updates to internal teams. The Manager is responsible to develop strategies for outsourced testing needs, considering timelines and schedules, risk mitigation and business priorities including the oversight of method transfer, qualification/validation, trending across analytical testing sites. The Manager, Quality Control supports CMC regulatory submissions for post-approval activities, including Annual Reports and testing site transfers. The Manager supports the Quality Culture through process improvements such as authoring and reviewing controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Contract Testing Laboratories (CTLs). May partner with Quality Assurance to Audit CMOs for compliance.

MINIMUM QUALIFICATIONS:

Bachelor’s degree in a science-related discipline, with focus in biology, chemistry, biochemistry, microbiology and/or biotechnology is required.  A minimum of 8 years of relevant and current work experience in the pharmaceutical industry, including 2 years of supervision or project management experience. Proven leadership capabilities in the application of current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP), current Code of Federal Regulations (CFR) in a Quality Control setting. Firsthand experience with method transfer, qualification and/or validation. Strong working knowledge of analytical testing techniques as applied to small molecule pharmaceuticals (both drug substance and drug product) (e.g. HPLC, dissolution). Demonstrated ability to express self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; adjust style, language and/or terminology with individuals of varying levels of authority. Strong understanding of drug substance and drug product commercial stability requirements.  Familiarity with JMP or other statistical software, is a plus. Experience in working with CMOs, is a plus. Travel of up to 15% may be required. 

PRINCIPAL RESPONSIBILITIES:

Manages contract manufacturers and testing laboratories to communicate and resolve quality control issues.

Analyzes results and methods, solves analytical problems, and meets regulatory expectations for drug substances and drug products.

Leads investigations and provides technical and compliance risk assessments.

Provides data-driven recommendations to internal teams regarding analytical activities backed by good science and cGMP principles.

Leads method transfers and implementation of appropriate analytical methods at external laboratories/partners in support of drug substance and drug product.

Authors and reviews technical and GMP documents (e.g., analytical protocols, reports, SOPs, specifications).

Prepares portions of CMC documents for regulatory filings (e.g. annual reports and post-approval submissions).

Actively participates in regulatory authority inspections and inspection readiness efforts.

Performs contract testing lab audits.

 

If you are interested in applying for an Open Position, please follow the directions below: 

  1. Submit your resume to redhillemployment@redhillus.com

  2. In the subject line put the full job title of the position you are applying for (including city), your name and the date of your submission. Note that we will only consider applicants that specify the Open Position that they are applying for.

  3. Cover letters are optional.


We offer a Comprehensive Benefits package that includes:

  • Medical, Dental, and Vision Coverage
  • Domestic Partner Coverage
  • Life Insurance
  • Short-Term and Long-Term Disability
  • Flexible Spending Accounts (Healthcare and Dependent Care)
  • Employee Assistance Plan
  • 401(k)

Job Applicants should be aware of job offer scams that are committed though the use of the internet and social media platforms. All legitimate correspondence from a RedHill Biopharma employee will come from a “@redhillus.com” or “@redhillbio.com” email address.