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Associate Director/Director, Quality Control

Associate Director/Director, Quality Control

The Associate Director/Director, Quality Control is a leader in the Quality organization and is responsible for developing and managing all aspects of the Quality Control program including ensuring the appropriate level of quality control for commercial activities.  This position will implement, design, develop, and manage cGMP training, document control, change control and all other aspects of the Quality Management System and will support the VP, Quality in providing input on strategic direction for the QA program and best practices for quality initiatives.  

This position is in our Raleigh, NC office. 

Minimum Qualifications:

Bachelor’s degree in a biologics-related discipline, with fundamental focus in biology, chemistry, biochemistry, microbiology, cell biology, and/or biotechnology. A minimum of 10 years of relevant and current work experience in pharmaceutical industry Quality Control. Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority.   Solid and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing quality control programs in a regulated environment. Ability to expresses self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; adjust style, language and/or terminology appropriate for the audience. Travel of up to 15% may be required. 


Principle Responsibilities:

Support third-party audits and regulatory inspections, including preparing Subject Matter Experts, representing Quality Control with inspection teams, and managing closure of commitments related to the analytical testing as required in response to observations and other findings.

Hiring, management and training of staff including resource utilization, definition of roles, career development, and performance management, while managing Quality Control activities in accordance with available budget, and resources.

Provide expertise and guidance in interpreting and implementing governmental and agency guidelines to assure compliance.

Provide Quality Control input to strategic goals in form of schedules, plans, and budgets.

Write, review, approve, and maintain Standard Operating Procedures.

Responsible for Out of Specifications, Out of Trend, and Laboratory investigations Design, development, implementation, and oversight of cGXP Quality Control Systems in the pharmaceutical industry. (21 CFR 210, 211, 600, 820,)

Author, review and approve SOPs, protocols, reports, specifications and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards.

Oversees Raw Material, Finished Good, Microbiology and stability programs related to RedHill products.

Provides technical analytical expertise for investigations and key projects.

Work closely with CMC group on Regulatory Submissions.

Interacts with R&D, Operations and Quality to identify additional analytical requirements for products.

Assures that contract laboratories personnel are meeting the required standards set forth by RedHill.

Prepares and revises technical documents. (Laboratory Protocols, change controls, laboratory investigations, CAPAs, SOPs, etc.)

Provides in depth technical and scientific advice and guidance to contract service providers and analysts.

Review all stability data and investigations related to the drug substance and/or drug products for various techniques. (HPLC, Dissolution etc.)

Implement quality control processes, specifications, validation reports; both externally and internally to support RedHill products.

Work directly with, and provide technical support, to operating entities (internal and CMOs) to ensure implementation of testing procedures and meet appropriate timelines and specifications.

Manage ongoing stability program for drug product and drug substances. Assure compliance with ICH guidelines on stability of pharmaceutical products.

Maintain and track stability timelines at all CMOs

Review stability data for trending and prepare stability documentation for regulatory submission.

Review and approve analytical methods and method validation protocols and reports.

Review and approve drug substance and drug product release testing data.

 

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.