Quality Systems and Third Party Contract Lead

AbbVie, Inc • Barceloneta, PR

44d

About The Position

This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations by managing the documentation review board to process and update complaint plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It also provides leadership to a team for the creation and/or update of material codes in the SAP inventory system and the electronic batch record recipes in POMs system. The Quality Systems and Third-Party Contractor (TPC) role also is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a professional, complaint and timely fashion. Additionally, the role provides leadership and oversight to the plant documentation retention center activities.

Requirements

• Bachelor's degree in Science, Engineering, or related field is required.
• Eight (8) years of experience in the pharmaceutical, biologics, or chemical industry in Quality Systems, Quality Operations, or Third Party Contracting.
• Three (3) years of experience managing direct reports is required.
• Strong knowledge of Quality regulations and standards for Pharmaceutical Industry (i.e. Quality Systems, FDA Regulations and Guidelines, Q7A, EU and Health Canada GMP regulations) along to Abbvie corporate, local, state, and OSHA regulations.
• Excellent verbal and written communication in both English and Spanish.
• Must be flexible and adapt to changes efficiently without disruption of the area's output performance.
• Knowledge of GMP, safety regulations.
• Computer literate including but not limited to SAP, Microsoft Office (Excel, PowerPoint, Word).
• Capable of handling multiple priorities. Strong problem solving skills. Strong Interpersonal and communication skills

Responsibilities

• The incumbent is responsible for the organization, administration, training, development, and supervision of personnel under the Documentation Center area. The incumbent hires, trains, develops, evaluates performance, gives wage adjustments, and administers established personnel policies.
• Documentation Quality System responsibilities include responsibility for the Documentation Management System and Change Request System used to update: Plant Procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation as well as oversight to the documentation periodic review process. The area is also responsible for: issuing, in a timely manner, electronic Batch Records to manufacturing areas in the POMs system, creating/updating material codes in SAP system.
• The incumbent serves as the main QA site reviewer / approver for all new and revised global and local specification documents (i.e. MTDs, RMSs, FMSs, PMRs, CMSs, PDSs, PCSs, STMs, etc.).
• The incumbent also will be involved in highly dynamic projects (i.e. New Product Introduction, etc.) or risk management activities as QA function to assure compliance with all applicable regulations, procedures and policies.
• Responsible for identifying and isolating quality problems and ensure that corrective action is taken. Implement and maintain the documentation change control system. Ensure that changes to documents that affect the final product's documents are verified for completeness accuracy and that the changes reflect regulatory requirements.
• Leads and manage Quality aspects with clients (Third Party contractors): quality agreements, event discussions, change management process and regulatory and compliance requests to fulfill TPC requirements and support Regulatory inspections for current and new market introduction. Maintains an effective liaison and cooperative relationship with Quality areas from Third Party contractors (TPC).
• Analyze, manage and maintain data for cycle times, touch times, and tasks/process lists for the continuous improvement of the QA processes performance.
• The incumbent might act as QA Compliance Manager (when he/she is not present) and is authorized to use independent judgment to make quality decisions related to the QA Compliance area, in accordance with policies, GMPs, and regulatory requirements.
• Assure fulfillments of environmental, health, and safety EHS requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees