		PRINCIPAL OBJECTIVE OF POSITION
		This position is responsible for maintaining several elements within the investigations Quality Systems frame work to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and Client policies. Incumbent must comply with Corporate and HR Policies, FDA, GMP, internal/external audit, and any other regulatory requirements. Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
	MAJOR DUTIES AND RESPONSIBILITIES State the most important activities and accountabilities of this position. The achievement of company or business goals. (Attach additional sheets if needed): Acknowledge, review and/or approve site investigations and CAPAs including their correlated Corrective Actions and Preventive Actions (CAPA). Maintains communication with internal & external customers to ensure compliance & timely completion of investigations activities. Reviews investigations related to process, products, utilities, microbiology laboratory and calibrations. Supports readiness of the facility for Regulatory Inspection. Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits. Documents any FDA communication between Site and agency. Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management. Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed. Generates, reviews and implements departmental procedure and forms to assure compliance with current practices or GMP’s trends. Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines. Ensures that Quality and Compliance is implemented in laboratory and operational areas and maintains it according with regulatory agencies expectations. Manages document including record retention program, compliance and custody of SOP’s, and review / approval / issuance of master documentation related to operational areas and; evaluates compliance of all procedure(SOP’s) and master documentation with regulations and Client Policies. Provides guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance. Coordinates Fact Findings documentation following Worldwide Quality and Compliance Directive and conducts root cause analysis to guarantee that underlying problems are identified and resolved. Support Field Alert Report/Biological License Application (FAR/BLA) and Recall investigations and provides tracking to any Site Planned deviation. Ensures that recall operations are capable of being initiated promptly and at any time. This includes that lists are maintained of customers of all batches distributed and of distribution information. Provides support to the Associate Director Quality Investigations System of monthly Quality Council meeting presentations.

		Develops impact assessments related to Policies and Directives implementation. Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule. Support the Inspection Readiness Program. Provides support to Site Projects. Provides compliance oversight and verifying compliance with Client and WWQ&C Policies and Guidelines and site cGMP compliance policies and procedures are addressed. Provides compliance oversight and verifying compliance with Client Policies, guidelines and regulations Liaison for regulatory initiatives Supports product submissions. Evaluates, follows up and approves Change controls for the site, including interaction with corporate support areas, other Client sites and third parties. Ensures Change controls are created according to local SOPs and corporate directives with all the appropriate requirements in placed for each change control. Supports actively the engineering, laboratories and Supply chain areas for Quality and Compliance documentation and site oversight providing coaching from Quality perspective. Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards. Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required. Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities. Evaluates OP’s, BR’s, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and Client Policies
KNOWLEDGE / SKILL / EDUCATION: Bachelor or Master Degree in Science (Degree or master in Chemical, Engineering, Biology or Microbiology). Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry. Fully Bilingual (Spanish/English) communication skills, both written and verbal are required. Strong knowledge of relevant GMP, FDA, EU regulations. Expert in the interpretation and application of regulations according with the intended use. Self-motivated, creative and team work oriented. Excellent interpersonal skills and the ability to interact with people at all levels. Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses. Self-motivated, creative and team work oriented. Self starter and good organizing and planning skills Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and Trackwise. Strong knowledge and experience in statistical tools Strong presentation skills Able to exercise good judgment Able to work under pressure Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary. Sense of urgency and analytical thinking are some of the critical competencies required for this position. Minimum exposure to hazardous areas.
B. Travel required (describe nature and frequency): • No significant travel required. Less than 15% of the normal work time. C. Overnight absences required(per typical month) • No significant absence in a typical month required. Use this space to provide any additional information that you believe would help in evaluating this job: • Demands of 40% of the time sit, 30% stand and 30% walk. • Ability to keep work pace and or meet deadlines. • Frequent writing in English and Spanish • Extreme attention to documentation nomenclature details, retention policy applicable and coordination are considered critical due to the variety and regulation of documents being handled. • Special gowning as defined and required in the manufacturing and required areas. Frequent material handling between 21-35 pounds (lifting)

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