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Grifols Shared Services North America, Inc Sr Manager, QA Complaints/Post Market Product Support in San Diego, California

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Summary:

The Senior Manager manages the Complaints Handling, Post Market Surveillance and Vigilance processes and provides quality strategic oversight for Grifols Diagnostic Solutions Procleix product lines. This position is Quality leader in providing guidance and strategic development for new and existing Procleix products and is the main Quality contact for providing guidance on any issue associated with the Procleix product lines.

Primary responsibilities for role:

Provides Quality oversight over the management of customer complaints, post market surveillance, and medical vigilance for all Procleix products.

  • Ensures effective complaint management, appropriate complaint investigations are conducted, and effective trending is utilized to ensure safe and effective products remain

in the field.

  • Achieves on-time closure improvements in complaint management.

  • Trends data and reviews of same for possible systemic issues that may be impacting one or more Procleix products.

  • Reviews recommended CAPAs, as part of complaint closure process, and determine their appropriateness for the Root Cause(s) that were identified.

  • Performs final QA Approval for Complaints Records, post marker surveillance and medical vigilance reports for all Procleix products.

  • Provides strategic direction with external partners (Hologic and other third-party developers and manufacturers) regarding instrument, hardware, and software, changes

and complaints.

  • Ensures appropriate issue escalation occurs related to any quality or compliance issues.

  • Provides the oversight and for inspectors during Health Authority audits/inspections, as necessary.

  • Serves as HA escort as required.

  • Provides support in other QA functions as needed.

  • Collaborates with Regional Quality Representatives to ensure efficient and effective resolution of complaints as they relate to Procleix products.

  • Leads the department in setting strategic objectives and deliverables for the customer complaints handling process.

Knowledge, Skills, and Abilities:

  • Knowledge of quality systems that ensure control of manufacturing processes in accordance with cGMP.

  • Knowledge of FDA and EU regulations, ISO requirements.

  • Skill in the use of computer systems for data compilation, managements, and analysis.

  • Experience with project management (problem solving and resolution) and general business principles.

  • Excellent written and interpersonal communication skills as well as strategic and conceptual thinking.

  • Experience with leading team or group projects.

  • Presentation and meeting organization/ facilitation skills required.

  • Ability to express view and opinions clearly, listen well, and accept conflicting points of view.

  • Team player and ability to multi-task.

  • Excellent analytical, organizational skills with a demonstrated ability to negotiate and resolve conflicts.

Education:

Bachelors Degree, in life or physical sciences, with experience in a clinical laboratory, diagnostic quality or technical area.

Experience:

  • At least 10 years related technical experience with significant QA, complaint handling, design control experience and/or pharmaceutical manufacturing.

  • Minimum of 5 years of supervisory / managerial experience

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:

  • May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 218568

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