Quality - Manager, Compliance

PRINCIPAL OBJECTIVE OF POSITION This position is responsible for maintaining several elements within the 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):1. Acknowledge conducts and/or approve investigations for Customer Complaints, External Complaints, approve Regulatory Corrective Actions and Preventive Actions (CAPA), Vendor Certification, Quality Agreements, Annual Product Review/Report for Finished Product and Systems and site licenses. 2. 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. 3. Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit. Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency. Create, review approves and track corrective actions related to internal and external audits. 4. Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management. 5. Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed. 6. Generates, reviews and implements departmental procedure and forms to assure compliance with current practices or GMP’s trends. 7. Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines. 8. Ensures that Quality and Compliance is implemented in laboratory and operational areas and maintains it according with regulatory agencies expectations.9. 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. 10. Provides guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance. 11. Support the Site Master File (SMF) and assists our regulatory section to handle and update documentation as part of our filing. 12. Coordinates Fact Findings documentation following Worldwide Quality and Compliance Directive and conducts root cause analysis to guarantee that underlying problems are identified and resolved. 13. 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. 14. Supports the Quality Risk Management program at the site participating in multidisciplinary teams. 15. Provides support to the Associate Director Compliance and Auditing in the preparation of monthly Quality Council meeting and presentations. 16. Develops impact assessments related to Policies and Directives implementation. Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule. 17. Ensures that all current vendors are qualified and conduct audits of approved Third Party Manufacturers and other vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program. 18. Support the Inspection Readiness Program. 19. Provides support to Site Projects. 20. Provides compliance oversight and verifying compliance with Client and WWQ&C Policies and Guidelines and site cGMP compliance policies and procedures are addressed. 21. Provides compliance oversight and verifying compliance with Client Policies, guidelines and regulations 22. Liaison for regulatory initiatives 23. Manages Licenses renewals 24. Supports product submissions. 25. Manages the Records Retention program 26. Creates, evaluates, follows up and approves Change controls for the site, including interaction with corporate support areas, other Client sites and third parties. 27. Ensures Change controls are created according to local SOPs and corporate directives with all the appropriate requirements in placed for each change control. 28. Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency. 29. Enforces critical analytical thinking in the Change Control management process. 30. Provides scientific input into change controls program management to assure all requirements to complete a change control are properly established and that no requirements are missing 31. Supports actively the engineering, laboratories and Supply chain areas for Quality and Compliance documentation and site oversight providing coaching from Quality perspective. 32. Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities. 33. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards. 34. Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required. 35. Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities. 36. Evaluates OP’s, BR’s, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and Client Policies.DECISION MAKINGA. Describe the position's responsibility for taking action, making final decisions and developing recommendations. Limiting factors might include existing policies, procedures, laws, regulations, internal controls, etc.:
• Notify immediate supervisor of any inconsistencies or violations to Company operation procedures and policies. • The incumbent is responsible of the compliance of the facility in terms of implementation, maintenance and challenge of the regulatory requirements which applied to GMP regulations in pharmaceutical, biopharmaceutical and medical devices industries. • The incumbent takes actions as deemed necessary and/or to communicate management in a promptly manner the actions required to ensure full compliance of the quality systems previously listed and to set priorities and meet deadlines within a complex and changing environment. • Inappropriate decision or action regarding a situation may result in regulatory action. • Unjustified delays in tasks execution may result in regulatory actions. • Position is expected to meet with the necessary areas to assure prompt solution of Quality and Compliance issues.B. Describe the nature of supervision received, the degree to which procedures, methods and goals are outlined by the supervisor, and the immediacy of supervision:On emergency situations, the incumbent may be required to make immediate decisions on the course of action of a lot without direct consultation. The incumbents must be able to work with minimum supervision as must be able to make compliance oriented decision taking in consideration the site procedures, cGMP’s, regulatory agencies , Client policies and guidelines. Must interact with governmental agencies, especially in the regulatory field, such as Food and Drug Administration, European agencies and others and must have the ability to provide back-up support to the Associate Director Compliance and Auditing during absence.CONTACTS Describe the most important working relationships of this position. Include the frequency, level, and the purpose of contacts necessary for effective performance:The incumbent will have interaction with personnel at all levels. Daily contact with Supply Chain Department, QC Laboratories, Warehouse, Technical Services, Manufacturing, Engineer and QA departments. Frequent communication with Management and Corporate Quality Unit is required. Continuous communication with external suppliers, external customers and headquarters are required.KNOWLEDGE / SKILL Describe the type and extent to which knowledge of a specific type is required to perform this job in a satisfactory manner. Where skills can be obtained through formal training / education and experience, list the type and amount of education and experience that would typically prepare an individual for this position:
 Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science.  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.WORKING CONDITIONS Describe the extent to which the job must be performed under working conditions that are considered undesirable, potentially hazardous, require travel, or require absence from home overnight:A. Describe exposure to any hazards / disagreeable conditions in the work environment: • 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)*Weil Group is proud to be an Equal Employment Opportunity Employer.*