This position is responsible for all QA activities that directly support execution of the process, both within the PET and in assigned areas outside the PET, ensuring compliance. These activities may include but are not limited to, batch release, change control and documentation, equipment and process validation, investigations, SOPs, supplier management and regulatory interactions. At the Senior Level, the incumbent will be trained and demonstrate some level of proficiency in all of the major responsibilities of the role. The incumbent must demonstrate a strong understanding of the area to which the individual is aligned. The incumbent will act as execution lead/process owner for one or more processes. Essential Duties & Responsibilities: Escalate to QA management (i.e., QA Manager / Compliance Operations Manager or Head of Quality) any discrepancies (potential or real) during daily operations. Provide expert advice on Good Manufacturing Practice/Good Development Practice/Good Laboratory Practice to Operations and ensure compliance with the associated quality standards. Review, approve minor investigations from Manufacturing Teams and Support Areas. Support major and critical site investigations. Conduct QA area investigations. Support local complaint investigations, identify and rectify any trends. Perform product release activities and recommend batch disposition. Collate the required documentation for product quality reviews within the required timescales. Ensure compliance with change management processes within the Process Execution Team (PET) and approval of associated documentation at a local level. Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgments, within general operating guidelines. Look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance. Produce and deliver Good Manufacturing Practice training within the Process Execution Team. Identify QA enhancement opportunities, and actively participate and coordinate with QA Management the required activities to implement these opportunities. Ensure plant readiness for any regulatory inspections including periodic walkthroughs. Execute and/or support local audits (both internal and external) to aid in developing follow up improvement plans to ensure ongoing compliance. Review and approve documentation generated as a result of experimentation, validation, new product technology introduction (i.e., Experimental Programs and Reports, Process and Cleaning Validation, Release Requirements Determination, Computer Validation Lifecycle documents, Risk Assessment for Qualification purposes, Installation Qualification, Operation Qualification, Technical Projects, Applications Change Controls, and CMC regulatory submission modules, among others). Review and approve Master Production Document (MPD's), SOP's, Field Change Notifications, Change Controls, Material Specifications, CAPAs, Minor complaints, Minor deviations and other GMP related documents within the Manufacturing Teams and Support areas. Prepare or review QA agreements and contracts for partner AZ sites, contract manufacturers, laboratories, vendors, and suppliers. Generate and/or revise GMP and regulatory CMC documents to ensure compliance with regulations, company procedures and/or standards, and regulatory commitments. Manage and maintain the Vendor Certification Program, Change Control, Regulatory CMC, Investigation System, and other compliance and quality systems. Support development and implementation of systems or CAPAs identified during audits, regulatory inspection, and pre or post-approval negotiation. Participate in the development and implementation of Quality Risk Assessments (QRA). Participate in project teams created towards problem solving or specific issues, to ensure GMP and regulatory compliance. Participate in the management and decision-making process of quality and regulatory compliance issues related to process, facilities and systems, and day-to- day activities that could impact the supply chain routine manufacture, startups, validation, and qualification activities. Coordinate and support the interdepartmental revision of documents to be submitted to the regulatory authorities. Liaise with AZRA and CMC RC to resolve submission problem areas or queries received from the health authorities. Coordinate with the regulatory agencies and IPR personnel all the necessary information and requirements for renewing the Company regulatory licenses, as required. Coordinate with the corresponding iPR and CMC RC representatives, PRHD, PR US Department of State, US Department of State, and the appropriate Embassies and Consulates, the preparation, modification, notarization, and legalization of documents for registering IPR products into or renewing CMC manufacturing licenses in the European and Rest of the World (RoW) markets (Registration Documentation). Training and mentoring of junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported. Knowledge, Skills, and Abilities: Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration. Adaptable to changing environment. Uses reason even when dealing with emotional topics. Up to date knowledge of cGMP and CMC regulations, and end-to-end supply chain management principles. Demonstrates accuracy and thoroughness, and attention to details. Looks for ways to improve and promote quality. Applies feedback to improve performance. Monitors own work to ensure quality. Meets productivity standards. Completes work in a timely manner. Strives to increase productivity. Works quickly. Business acumen focused on ensuring continuity of supply, cost-savings, and reducing non-value adding activities. Displays willingness to make decisions. Exhibits sound and accurate judgment. Supports and explains reasoning for decisions. Includes appropriate people indecision-making process. Makes timely decisions. Ability to develop understanding and knowledge of the regulations, products, and processes being handled. Good communication across all levels or the organization and capable of building and maintaining open lines of communication. Strategic and tactical customer stakeholder management. Responds promptly to customer needs. Solicits customer feedback to improve service. Responds to requests for service and assistance. Meets commitments. Maintains confidentiality. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Generates creative solution. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. Develops alternative solutions. Works well in group's problem-solving situations. Strong problem-solving skills Knowledgeable in LEAN principles, strategies, and techniques. Ability to apply and work with mathematical concepts such as probability and statistics. Understanding of statistical data and capable of drawing or reaching conclusions from supporting data concepts (i.e., normal distribution, percentages, ratios and proportions to practical situations). Basic Project Management skills Balances team and individual responsibilities. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Supports everyone's efforts to succeed. Prioritizes and plans work activities. Uses time efficiently. Sets goals and objectives. Attendance/Punctuality - Is consistently at work and on time. Ensures work responsibilities are covered when absent. Arrives at meetings and appointments on time. Minimum Requirements: Levels of General Education and/or Experience: Bachelor's degree in a Sciences / Technical field such as Pharmacy, Biology, Chemistry or Engineering and at least seven (7) years related experience in the pharmaceutical industry with emphasis in Quality or Compliance position. Language Skills: Fully Bilingual (English & Spanish) Computer Skills: Intermediate knowledge of Microsoft Office applications (Word, Excel, Project, PowerPoint, Outlook, Visio) or similar computer applications. Intermediate knowledge of databases/application systems (i.e., SAP, Global LIMS, LDMS, TDMS, TCMS, OCM, TrackWise and GCM applications). Certificates, Licenses, Registrations: Licensed chemist or registered pharmacist highly desirable. SDL2017
