**Description** The Manager QA role leads and oversights the disposition of raw materials, packaging components, in-process materials, and finished products on a timely fashion to assure business continuity. Manages the QA Release Team according to company policies and corporate business plans. Assure that QA Release functions are in alignment with product supply plans and performed according to regulatory requirements based on products market authorizations. Collaborates with other functional areas to assure compliance with site and area KPI’s. Provides technical competence in events assuring agile and compliant resolution. Supports Quality Systems as SME, regulatory inspection and corporate audits and serves as a backup to the SR AD Quality & Compliance in the event of absence. This position also handles emergency and critical tasks within the QA team. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Leads and oversight of the disposition of raw materials, packaging components, in-process materials, and finished products timely. Collaborate with other departments, such as Production, Planning, Warehouse to assure achieve product supply. + Assures proper usage decisions for batch/lot release in SAP according to the Market Authorization of the products. + Coordinate the timely issuance of Quality KPI's (ROT). Collaborate to assures proper implementation and interpretation of KPI's. Take agile actions if necessary to achieve the KPI's goals. + Ensure that any site event or discrepancy is investigated accordingly. Coordinate and/or conduct the investigation. Initiates (as needed), assesses, reviews and approves deviations. Assign deviations to team members. + Collaborate with site's areas to perform immediate impact assessment on deviations to determine whether a quarantine, a field alerts are warranted. Writes or participates in deviation investigations for determination of root cause and product impact. Assures proper CAPA’s identification. + Leads and collaborate with all site areas to assure timely completion of deviations and CAPA’s, avoiding impact to the product release. + Direct the resolution of major issues applying Quality Systems knowledge and cGMPs. + Provides guidance to the site's area and technical teams in the use and interpretation of company policies, procedures, standards, guidelines. Reviews, revises and/or approve SOP’s as needed. + Assures that QA documentation/procedures are maintained in compliance with current regulatory expectations/registrations according to the products Market Authorizations. + Collaborates with the Internal Audit Program assuring the participation of QA Auditors team in monthly area's walk troughs and internal audits. + Provides guidance to the areas to maintain a good Inspection Readiness status identifying inefficiencies / problems, and solutions timely. + Seeks opportunities for continuous improvement focus in activities to strengthen site compliance posture and simplify processes. + Supports all activities required to assure compliance with cGMP’s on new products introduction/ site transfer assigning personnel and providing compliance posture. + Manage requests for documentation associated to regulatory submissions and/or samples needed are provided timely. + Coordinate the activities to provide audited and/or certified information on time for documents needed for regulatory filing. + Supports regulatory and corporate audits as SME, escort or any other role as required. Coordinate team participation as needed assuring documentation completeness, review and availability. **Requirements** + Bachelor degree from an accredited institution in Sciences (Engineering, Biology, Chemistry, Pharmacy or scientific discipline like computer science). + Minimum of seven (7) years of experience in a pharmaceutical, bio-pharmaceutical or medical devices cGMP environment. + At least five (5) years of experience working in quality, compliance or related field. + Minimum of three (3) years of supervisory experience. + Broad experience in analytical procedures, instrumentations, manufacturing practices and procedures is highly preferred. + Audit preparation for regulatory agency audits/inspections and participation through demonstration of job tasks during inspections may be required as needed. + Strong understanding of cGMP's, FDA, EMEA, ICH regulations, MCA, and others. + Excellent organizational, supervisory, and leadership skills to manage a team and technical staff. + Technical English and Spanish, oral and written communication. + Leadership skills, including but not limited to delegation, motivation, influencing, conflict management, teamwork, and negotiation. + Problem solving and decision making skills. + Ability to work with people at all levels. + Conflict resolution and technical writing skills. + Root cause analysis and problem solving. + Influencing and negotiation skills. + Communication skills in Spanish and English (technical), verbal and written. + Able to analyze complex problems in technical systems to gather conclusions of its functionality. \#LI-KD1 **Eligibility Requirements:** + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** + Manages a comprehensive response to regulatory and internal cGMP's observations associate to area of expertise. Supports production and service areas in the evaluation of responses according to cGMP's and company policies. + Drives the continuous improvement of processes, systems and culture in the organization. Model behaviors aligned with the site continuous improvement mindset, implement ideas, programs and change management initiatives that will have sustainable long-term benefits according to the organization strategic goals and objectives. + Drive Environmental, Health and Safety (EHS) compliance in the organization. Actively engage and role model behaviors aligned with the site EHS philosophy and assure full on-time compliance with applicable EHS training programs and requirements. + Empower, motivate and drive people development. Assure annual performance review activities be conducted on time. Promote and engage with direct reports by conducting frequent 1:1’s to discuss career development opportunities, support annual TDD activities and assure individual development plans are up to date and aligned with site priorities and strategic business needs. + Complies with all environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any environmental events. Complies with regulatory training, procedures, policies and guidelines. + Support preparation of department budget for Quality Assurance area. Monitors spending to stay within prescribed limits and proposes and develop new budget information. Identify and explore new ways for savings to improve spending. + Other tasks or projects as assigned. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.