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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.
Summary
The Quality Assurance (QA) Manager assures consistent quality of production by developing and enforcing good manufacturing practices (cGMP) systems to ensure overall compliance with operating procedures, regulatory requirements and reports the facility compliance status to Operational and Quality management. This position has primary responsibility for the quality acceptance and release of plasma product shipments and manages the daily activities of the Plasma Logistic Center (PLC) quality assurance staff.
Responsibilities
Manages the daily activities of the PLC quality assurance staff and ensures that required activities are performed related to the receipt, storage, clearing, processing of lookback alerts, quarantine of unsuitable units, and release of source plasma for further manufacture or sales.
Responsible for the QA release of plasma from PLC and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.
Maintains the PLC deviation management and quality feedback system to notify plasma collection centers (internal and external) of nonconformities noted during the plasma receipt and plasma processing.
Investigates and documents deviations noted as a result of routine compliance reviews, internal and external audits and customer complaints.
Interact with facility management and other members of PLC management to assure understanding of audit findings.
Analyze and evaluate reports prepared by facilities in response to audits performed. Evaluate for adequacy of corrective actions, completeness of report and close audit when satisfactorily completed.
Monitors Plasma Operations in order to maintain compliance with all applicable regulations, both foreign and domestic. Participates in internal audit of the PLC facility.
Leads activities needed to assess facility compliance with SOPs, applicable domestic regulatory agencies such as FDA, international regulatory agencies such as EMA, federal and state regulations. Responsible for coordinating and conducting the Internal Audits at the PLCs.
Participates in the writing and revision of policies and procedures related to the PLC.
Monitors the PLC in order to maintain compliance with all applicable regulations.
Hires quality assurance staff and implements training programs, careeer advancement objectives for quality assurance staff, performs performance appraisals and enacts corrective actions as needed to and including termination.
Meet quality assurance and company financial objectives by monitoring department costs.
Knowledge, Skills, Abilities
Strong analytical, organizational and interpersonal skills. Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia/ICH and ISO Guidelines. Excellent written/verbal/leadership skills. Must be able to make sound decisions that may affect the quality purity or efficacy or a drug product. Anticipates and identifies problems; analyzes situations; consider alternatives; monitor and evaluates results in a systematic manner. Displays a commitment to quality in terms of people, product and processes. Computer literate, with experience in use of Microsoft applications
Education
BS degree in Biology, Chemistry or related Science or Engineering.
Experience
Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals. Project or technical leadership experience required. Supervisory or management experience preferred.
Compensation and Benefits:The estimated pay scale for the Quality Assurance Manager in City of Industry, CA is $127,500 - $185,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
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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 : CA-City of Industry:USCOI - City of Industry, CA
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