Over the past five years our client has enjoyed double digit global growth though a judicious strategy of acquisitions and sales growth. This highly regarded pharmaceutical company is now looking to hire a bright, action-oriented self-starter to take on the challenge of delivering on its highly ambitious future plans.
Reporting to the Executive Director of Quality Operations, this position is responsible for technical transfer, troubleshooting, and technical documentation related to all Quality Control (QC) activities supporting both new product commercialisation and consistent delivery of commercial products. This is to meet regulatory, quality, supply volume, timing, and cost objectives of the business.
The position holder will be an analytical expert for Biological drug substance and Biologic Drug product analytical test methods, test method validation and test method transfers both internally and externally. This position is responsible for quality control (QC) tasks such as Drug Product quality complaints handling from a QC perspective and QC management of assigned critical vendors for aseptically manufactured product. The Associate Director, Quality Control and Technical Support, furthermore executes QC functions such as performing deviation, investigation, CAPA, method transfer, and change control tasks as needed.
As a key member of the Quality Operations team, this position will be working within the Technical Operations organisation and its partners to collaborate on the different Quality Topics and relevant QC projects assigned.
Duties and Responsibilities
? We are seeking a candidate who has a strong background in biological testing and also testing strategy, this would include the full analytical life cycle from development phase III, through transfer to commercial.
? Reviews and updates QC related procedures for the Quality Management System as per process ownerships and business needs.
? Provides QC support, technical advice and information to the various departments within the organisation for various quality topics as required 2
? Supports the QA Ops function by addressing deviations, investigations and CAPAs pertaining to assigned quality topics - Supports, coordinates and/or documents investigations related to the Recall/Mock recall process as per business needs.
? As lead QC representative, coordinates and supports vendors in the completion of the following tasks:
o CTL Vendor qualification, approval activities, identification of potential gaps
o Company products pro-active QC trending and APQR compilation
o Stability program management including protocol and reports review and approval
o Provide QC support and guidance to the handling of vendor deviations (both OOS and OOT) and change control
o Coordination of contract test lab investigations (e.g. complaints investigation),
o Communication of changes in specifications to contractors and suppliers
o Communicates relevant vendor related QC information within the company as appropriate
o QC tasks triggered by regulatory submissions, etc. - Provides Senior Management with appropriate CTL vendor related KPIs as required.
? QC Lead for new projects or new products to be implemented at assigned company vendors sites
? Participates in Company TOPS project meetings as appropriate, defines the necessary action plan for QC aspects, co-ordinates the implementation of resulting actions with the vendor and within Company.
? Reviews (or coordinates the review) and approves associated Company CTL vendor QC documentation as required.
? Communicates relevant vendor related QC information within Company TOPS team as appropriate including liaison with project Technical Lead/TOPS Lead.
? Acts as QC representative (SME) during regulatory authority's inspections and contributes in various roles to the successful execution of regulatory authority audits.
? Contributes as lead auditor or audit team member to internal audits, external audits and vendor qualifications (manufacturers and laboratories) managed by QA Operations/Corporate QA function.
? Provides instructions for the constant development of the Company Quality Operations KPI's.
? Develop collaborative partnerships with key stakeholders in contract development and manufacturing organisations by leveraging technical and operational expertise. This is to ensure best practice and ongoing improvement.
? Lead assessment of CTL providers; identify viable alternates; determine and influence long-term QC strategy and where appropriate lead effective new technology/method transfer projects.
? Partner supply-chain-team in negotiation of contract agreements with prospective suppliers/CTL.
? Identify appropriate measures of CTL performance - track, report and implement required corrective action where targets are not met.
? Lead and/or participate in cross-functional teams or committees working across various areas of Company activity (including but not restricted to QC related activities).
? Direct investigations of CTL and other deviations, identify vendor compliance issues and work with internal departments and external contract organisation(s) to effectively resolve, prevent and escalate where appropriate.
? Lead strategic QC optimisation activities to ensure reliability and cost-effective supply across a growing and
increasingly diversified portfolio of small molecule drug products and analytical technologies.
? At least 10 years of experience within manufacturing or technical operations in Quality Control and/or Quality Assurance in the pharmaceutical industry (solid oral dose, small-molecule).
? Minimum (MSc) in Biology, Chemistry or Pharmacy, science or related field; PhD/Pharm D preferable.
? Thorough understanding of good manufacturing/laboratory practices (GMP/GLP) and FDA regulatory requirements.
? Solid understanding of Biological dosage forms, manufacturing processes and QC testing methods including Microbiologic and Sterility testing.
? Experience with external third-party liaison especially with contract laboratories.
? Proven experience in design, specification and quality control of drug product packaging and of packaging operations.
? Proven track record in identifying opportunity, engaging and leading cross-functional improvement efforts.
? Solid understanding of the aseptic manufacturing processes and QC testing involved in the pharmaceutical industry
? Experience in commercialization of drug product including knowledge of project management and review; equipment and facility qualification; technology transfer and scale-up; risk assessment and experimental design; process and cleaning validation.
? Good understanding of QP concept and associated duties including liaison with Health Authorities.
? Analytical mind, ability to assess new products or new projects to define and implement the appropriate action plan for integration into the Company Quality System
? Experience in combination products would be of advantage.
? Ability to support regulatory submissions.
? Ability to travel internationally as required.
This role requires good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.
We value and look to recruit people with the following approach to work.
? Action Oriented
? Problem Solving
? Strong Technical skills
? Priority Setting
? Drive for Results
? Strategic Agility
? Deals with Ambiguity
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