Senior Quality Assurance Manager - Sterile Products

The Judge Group; New Jersey; On-site; USD 100,000 - 125,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is looking for a Senior Quality Assurance Manager to oversee Quality Operations. The role involves ensuring compliance with quality management systems, interacting with external business partners, and overseeing the product release process. Candidates should have at least 10 years of experience in the industry and a degree in a relevant scientific field.

Qualifications

• 10+ years of experience in the Pharmaceutical Industry.
• Experience in GxP laboratory practices.
• Strong organizational skills with the ability to manage multiple projects.

Responsibilities

• Provide guidance and supervision to the Quality Operations group.
• Review and approve documentation such as Method Validations and Manufacturing Records.
• Support technical transfer and validation activities with external partners.

Skills

Leadership skills

Regulatory compliance

Interpersonal skills

Technical writing

Troubleshooting

Education

BS in Pharmacy, Chemistry, Microbiology or Biology

Job description

Senior Quality Assurance Manager - Sterile Products

Senior Quality Assurance Manager - Sterile Products

Direct message the job poster from The Judge Group

The Senior QRM Operations will be interacting primarily with Company’s external business partners/CMOs. The incumbent will have responsibility for commercially approved products for routine operations and is responsible for supporting the adherence to Company’s Quality Management System. The position will require in depth knowledge of Quality Systems including activities such as validation, troubleshooting/ investigation support, complaint handling, change control, product release, inspection support, etc. The individual will also support the technical transfer of products to/from various CMO’s. The individual serves as a critical link to Company’s external partners.

RESPONSIBILITIE

Primary responsibilities of this role include, but are not limited to, the following

• Provide guidance and supervision to the Company Quality Operations group (including setting goals, performing performance reviews
• Review and approve documentation such as Method Validations, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Reports, Equipment Qualifications and similar documents as directed by Quality Management Inspections and Audits
• Prepare / Support preparation activities for regulatory inspection
• Evaluate regulatory agency findings from inspections conducted at CMOs/CPOs/analytical Laboratories, etc
• Support the design and implementation of system / process improvements where opportunities are identified (Commercial), including associated CAPA’s
• Support technical transfer / validation activities with external business partners / CMOs
• Manage the Finished Product / Bulk Drug Product Release System
• Execute the Company material release procedure(s). Manage release priorities per business deadlines. Work directly with CMOs and partners to resolve related questions/issues
• File, retrieve, and maintain organized record
• Communicate with external business partners / CMOs regarding quality related issues and Quality Agreements
• Provide investigation/trouble-shooting support as needed. Review and approve investigations, unexplained discrepancies, failures, and out-of-specification results. Evaluate if there is any quality impact to process/product and take appropriate action
• Track metrics for external business partners / CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third-Party Quality Key Performance Indicators
• Change Management Program
• Process change controls for all systems requiring change control support (e.g. specifications for raw materials, drug product intermediates and finished drug products, validation protocols and reports, master production and packaging records, cleaning records, and analytical methods)
• Maintain change control electronic records in EQMS
• Review, assess, and approve change controls as required by SOP’s
• Support training of company personnel on change control system
• Support the corporate Training Program, when / if needed
• Support the corporate audit program as needed / required
• Keeps abreast of industry regulations and cGMP trends. Stays informed of FDA and ICH Guidelines related to GMP (Commercial)

QUALIFICATIONS

Position requires the following education and qualification prerequisites

• Excellent leadership skills in all areas of communication, influencing, collaboration and decision-making.
• BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 10 years’ experience in the Pharmaceutical Industry preferred. Other degrees will be considered based on extensive industry experience.
• Experience in GxP laboratory practices.
• Release of materials and products supporting both development and commercial activities. Has knowledge of GxP quality systems, US FDA regulations and ICH guidance documents.
• Experience with various manufacturing / filling processes associated with Sterile injectable/combination drug products. Experience
• Experience in troubleshooting and conducting investigations.
• Must hold strong interpersonal and communication skills. Must have the ability to work well with diverse groups including the ability to work in a team environment. Must also display strong organizational skills with the ability to lead team meetings and to manage multiple projects at one time.
• Strong technical writing and computer skills also required.
• Must display the ability to work independently with little or no supervision and plan and accomplish set goals.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Manufacturing, and Product Management

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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