QA Operations Manager

QA Operations Manager

Amicus Therapeutics

Dublin, Ireland

Position Summary

• Maintain a Patient Focused Mindset. The QA Operations Manager role plays a major part in the market supply of clinical and commercial finished products to Amicus patients globally. The patient will be the core of any decisions related to product quality. An uncompromising focus on product quality is required.
• Develop and maintain positive relationships with key internal and external stakeholders (CMO’s), this role will actively be involved with the day-to-day management of CMO quality activities. This role will serve as a single point of contact between the Amicus Quality Team and the CMO.
• Manage & drive closure of all related QA documents associated with the Amicus QA batch clinical and commercial release process e.g., Batch records, Deviations, CAPA, KPI reports, Change Controls, OOS/OOT’s to facilitate the continued global market supply of Amicus Clinical and Commercial Finished Product.
• Maintain flexibility and be able to adjust to the business needs in a fast-paced work environment, whilst maintaining and promoting focus on Amicus Product Quality and QA compliance.
• Escalate significant Quality Events to Senior QA Leadership as a priority to ensure effective solution and resolutions are in place to ensure the continued supply of clinical and commercial finished product to Amicus patients.
• Execute QA operations in support of and in concert with Senior QA Leadership to drive results, establish objectives and ensure appropriate steps are taken to identify compliance gaps and put corrective and preventative actions in place.
• Maintain a Practical Process Improvement and risk-based mindset within the QA Operations organization to identify process gaps and functional alignment needs leading to process improvement initiatives.
• Serve as a Role Model Team member demonstrating strong communication and interactions with colleagues at all levels in the Amicus organization, promoting positive employee/team dynamic relations.
• Provide QA support for the review and approval of qualification/validation protocols and reports for manufacturing processes, QC Analytical methods, cleaning processes, equipment and facility validation activities and computerized systems.
• Follow all applicable regulatory requirements, cGMP guidelines, and industry guidance documents as required by the job function. Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules.
• Ensuring compliance with all compendia and internal requirements (SOPs, Quality Technical Agreements, General and Informational Chapters in multiple compendia, as applicable).
• Support with the compilation of all necessary data associated with the drafting, review, and approval of Annual Product Quality Review (APQR) documents. Collaborate on a cross – functional level to ensure the Amicus Internal APQR SOP process and timelines are met.
• Lead/Assist with routine GMP/CMO/CLO audits as required by the business.
• Assist with the investigation of finished product temperature excursions in conjunction with Amicus 3rd party logistics and distribution providers. Adequately assess and evaluate product quality impact when temperature excursions or product storage conditions impact finished clinical/commercial product supply to Amicus patients.
• Perform high level review and or updates to Quality Technical Agreements in collaboration with Amicus approved vendors.
• Performing other duties related to the position when required by Senior QA Leadership.

Requirements

Educational Requirements

• Minimum of a bachelor’s degree in the Sciences (e.g. Chemistry, Biology, Pharmacy, Pharmaceutical Quality Systems, Chemical Engineering).

Professional Work Experience Requirements

• Must have 5 years biotech/pharmaceutical industry experience working in Quality Assurance/Quality Control, preferably in a batch/data review or approval role.
• An in- depth knowledge of manufacturing operations and current Good Manufacturing Practices and Quality Systems is essential.
• This QA Operations Manager position will have demonstrated experience working on cross functional teams managing outsourced programs, with demonstrated experience in overseeing and managing CMO/CLOs.
• Experience in developing, reviewing, and approving cGMP related documents (SOPs, protocols, reports, deviations, change controls, quality technical agreements, APQR’s etc.).
• Working knowledge of FDA, Ph Eur., EMA GxP regulations and ICH guidance documents.
• Experience in audit related activities, Regulatory Inspections/Vendor Audits.

Experience and Skills

• Ability to work within a high performing team environment.
• Comprehensive hands-on knowledge and experience with oversight of QA/QC activities, including data review, deviations, and change controls.
• Strong problem-solving and troubleshooting skills.
• Ability to work independently and make risk-based decisions.
• Strong verbal and written communication skills.
• Strong interpersonal skills/networking skills.

Other skills/Attributes

• Demonstrated alignment with Amicus Mission Focus Behaviors.
• Passion for rare disease and patient focused.

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Ireland      Manufacturing and Logistics      Quality Assurance      Amicus Therapeutics