Senior Manager, Quality Control Laboratory
- Barceloneta, PR
- Permanente
- Tiempo completo
- Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions or incident.
- Direct RM & Incoming laboratory operations and programs such as RM & Incoming methods for materials, excipients, API, commodities. Testing of raw materials, commodities, USP water and cleaning samples.
- Responsible for elevating to the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Reviews and approves laboratory instrumentation, utilities, and facilities qualification and labs system life cycle documentation.
- Responsible for all raw and incoming materials and commodities (including ERP approval) in the Quality Control (QC) laboratory including direct reports and budgetary responsibilities.
- Serves as the standalone laboratory systems and site Maximo administrator. Comply with AbbVie policies, ABL plant procedures, Food and Drug Administration (FDA), EMA, and other applicable regulatory agencies cGMP regulations and requirements.
- Responsible for end results of the Incoming Quality Assurance area. Assures that all incoming materials received at ABL are inspected, sampled, tested, and disposition according to established policies and procedures. Provides strategic direction for area of operation and ensures tactical objectives are met.
- Responsible for front- and back-room support activities for the RM and Incoming Lab during internal audits, Periodic Validation Review, Annual Product Reviews, and process data reviews and inspections.
- Represents the decision-making authority on change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests. Leads the implementation of Quality-related projects, including metrics.
- Manages a team of quality professionals. Directly responsible for the effective organization, administration, training, and supervision of their functional area.
- Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs; qualification and validation protocol writing, review, and approval.
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
- Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr. day) is required
- Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
- Bachelor’s degree Science (Chemistry or Biology) with 10 years of pharmaceutical (parenteral biologics preferred) Quality experience (preferably in QC) or an equivalent combination of education and experience.
- Experience managing raw and incoming materials.
- Knowledge in raw materials /Incoming Materials programs under ANSI guidelines is required.
- Supplier Quality Programs knowledge and experience.
- The selected candidate must be fully bilingual written and verbal, both in English and Spanish.
- Experience with SmartQC, LIMS (Sample Manager), Empower is desired.
- Previous experience leading teams.