Manager, QA Release

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.

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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.