Quality Assurance Manager - CLIA/CAP Experience

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Laboratory Solutions in San Marcos, Texas is seeking a Quality Assurance Manager. The Quality Assurance Manager will be responsible for ensuring organizational adherence to corporate quality and compliance processes, including quality management systems reviews, data integrity assessments, and risk management assessments.   Collaborates with donor center leadership and shared services to coordinate external inspections (e.g. regulatory, customer, etc.).  Manages and oversees audit planning, audit responses, and Plasma Master File (PMF) updates to maintain donor center compliance with regulatory requirements, Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP), and customer requirements.

Primary Responsibilities for role:

• Leads and develops team of Quality Assurance Specialists (QAS) to facilitate pre-inspection, during, and post-inspection activities associated with inspections. Including oversight of the following activities:
• Site Master Files (SMFs) preparation required for external EMA inspections.  Provides training for preparation and maintenance of this documentation.
• Developing, writing, and reviewing both internal and external audit responses / CAPA plans related to corporate citations.
• Coordinates and organizes final responses to regulatory inspections / audits (FDA, EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits), including submission to the relevant   Authority.
• Supports donor centers with customer audits, completes requested customer-driven documents, and assists with development of audit responses.
• Coordinates and hosts Regulatory inspections, both domestic and foreign.
• Tracks and provides ongoing comprehensive updates on European regulatory authorities, as well as customer requirements to Associate Director.
• Tracks and trends inspection/audit observations.  Analyzes data, recognizes areas of improvement, and offers solutions to enhance compliance.
• Leads QAS team in assuring corporate quality functions are routinely reviewed and properly analyzed to drive improvement and mitigate risks.     
• Manages Corporate Deviation Reporting for Plasma Procurement, ensuring records are adequately written and timelines are met.
• Reviews Corporate deviations and tracking / trending data to assist with continuous improvement.
• Initiates Change Requests and writes Standard Operating Procedures as needed based on identified improvement opportunities.
• Oversees and manages Department tools utilized (e.g. master inspection schedule, SMF and response tracking, commitment database).
• Oversees the completion of Data Integrity Risk Assessments/performs Data Integrity Risk Assessments as needed.
• Serves as the Quality Risk Assessment Administrator.      
• Manages and leads activities of QAS team, including work duties, training, and scheduling.
• Travels up to 25% or greater if demand requires.

Additional Responsibilities

The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities.  They must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.  They must know the European Pharmacopoeia (EP) and other European Guidelines as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).  They must have strong interpersonal skills with the ability to communicate effectively with persons from other cultures and other points of view.

Knowledge, Skills, and Abilities

• Maintains a high level of professionalism.
• Follows policies, procedures, and regulations governing work and the work environment.
• Models and demonstrates high standards of integrity, trust, openness, and respect for others.
• Takes initiative; looks for opportunities to act and contribute to the team's success.
• Demonstrates good stewardship of expenses: makes good use of unsupervised time.
• Offers support to team members at any level in achieving their goals.
• Provides outstanding servant leadership and receives feedback constructively.
• Appropriately follows the chain of command and knows how to get tasks accomplished.
• Demonstrates openness to team members’ suggestions.
• Shares knowledge, resources, etc. to reach common goals.
• Demonstrates effective oral and written skills and communicates information accurately based on fact.
• Uses respectful, conversational tones in e-mail messages.
• Understands the impact of own behavior on others – and adapts to change with optimism.
• Ability to think through problems clearly and logically.   
• Completes assigned tasks within the required timelines.
• Demonstrates Critical thinking and attention to detail.
• Listens and communicates in a transparent way, building relationships that foster professional self-esteem.
• Acts as a role model of the corporate values and reinforces them among his/her team.
• Uses facts and figures to support positions and influence others.
• Promotes and applies professional ethics.
• Knowledgeable of current regulatory standards.
• Organizes tasks and projects effectively.
• Demonstrates and encourages good teamwork and high levels of collaboration.
• Contributes feedback where necessary.
• May represent Compliance on projects, workgroups, Process Improvement Teams.
• Builds strong and trustworthy working relationships with team members and internal / external partners.
• Focuses on the scope and the solution rather than the problem; strives to overcome possible obstacles.
• Shares innovative ideas, creates buy-in and translates ideas into practice.
• Looks for simplification and improvement of processes; creates simple procedures and alternatives that may benefit the company.
• Embraces change and continuous improvement

Education

A BS degree is required, with a preference for an MS degree in a life science field preferred.

Experience

Typically requires a minimum of 6 years of related experience.  Project or technical leadership experience required.  Supervisory or management experience preferred. Experience with Quality systems and Regulatory Compliance is desired. Plasma industry experience is beneficial.

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.  We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : USA : TX-San Marcos:USSMC - San Marcos Lab, TX 

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