Quality Compliance & Governance Director
The Quality Compliance & Governance Director directs and oversees a strategic vision for the quality governance process on behalf of Alta Resources and our clients in accordance with the organizations' strategic mandates of Governed Growth, Achieved Profitability, Applied Innovation, andEmployee Engagement. The Quality Compliance & Governance Director will position the capabilities of Alta Resources to solve business issues on behalf of our clients.
These activities are carried out in accordance with recognized principles of effective quality governance programs, applicable regulatory requirements, Alta’s and client's governance policies, procedures, objectives, and initiatives, and Six Sigma philosophies to promote compliance, mitigate risks, obtain optimum results, ensure efficiency and economy of operations, and maximize established program objectives.
The Quality Compliance & Governance Director identifies and interprets laws and regulations applicable to Alta’s operations, the services offered to and performed on behalf of its’ clients, the regulatory classification(s) of products serviced for clients, and the states, provinces and countries for which services are provided. S/he communicates regulatory requirements and provides guidance and oversight to ensure they are integrated into policies and procedures and that those policies and procedures are implemented and effective.
The Quality Compliance & Governance Director also serves as Quality/Compliance Director for all Client Programs subject to U.S. Food and Drug Administration and/or Health Canada Current Good Manufacturing Practice (cGMP) and/or Quality System Regulation (QSR) and/or Drug/Medical Device Pharmacovigilance and Safety Reporting regulations, ensuring procedures required by applicable laws, regulations, standards and Client are developed, implemented and maintained and records maintained.
Essential Duties & Responsibilities
Develops and maintains Alta’s Quality Management System using a process-oriented and risk-based approach to enable compliance with regulations relevant to Alta operations.
Manages the Audit Program by performing or facilitating internal audits, hosting customer and/or cross-site audits, reporting the audit results to leadership and stakeholder clients and preparing or reviewing responses to audit findings and inspection observations.
Provides regulatory compliance, quality management and risk management expertise and guidance throughout the organization and to clients as may be needed, including, but not limited to corrections, corrective actions and preventive actions and root cause investigations.
Monitors and analyzes quality metrics and incorporates Six Sigma practices and philosophies into quality improvement initiatives to achieve client and Alta goals and to develop corporate best practices and efficiencies.
Manages and maintains the Electronic Document Control (EDC) system and records management, providing accurate, approved, version controlled Standard Operating Procedures that effectively govern the services provided for clients.
Provides ongoing reinforcement of quality management philosophies and a compliance culture among all employees.
Identify and utilize resources to maintain a current understanding of laws and regulations and recognized best practices applicable to Alta’s operations and the services that it offers and provides to clients, including, but not limited to:
- Corporate and Facility registrations, licenses and permits required based on services provided and products stored or shipped
- Current Good Manufacturing Practice and Quality Management System Rules and Standards:
- U.S. Food and Drug Administration (FDA) Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP) (21 CFR §§210-211)
- Quality System Regulation (QSR) for Medical Devices (21 CFR §820)
- Dietary Supplement cGMP (21 CFR §111)
- FDA Cosmetic Good Manufacturing Practice Guidelines
- Health Canada Good Manufacturing Practices Guidelines
- ISO 9001, ISO 9004 and ISO 13485 quality management standards
- U.S./Canadian Pharmacovigilance/Drug Safety Recordkeeping and Reporting:
- FDA Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance (Adverse Event/Product Quality Compliant event identification, coding, recordkeeping and reporting)
- FDA Postmarketing Reporting of Adverse Experiences Guidance;
- Product recalls
- Computer System Validation/Electronic Record and Electronic Signature Regulation:
- FDA Electronic Record and Electronic Signature (and computer system validation) Rule (21 CFR §11)
- GAMP and NIST validation guidelines
- U.S./Canadian Consumer/Health Information Security and Privacy Protections and Breach Notification Laws and Regulations:
- U.S. DHHS HIPAA/HITECH Privacy and Security Rules (45 CFR §§160, 162, 164) and associated NIST standards
- U.S. Federal Trade Commission Consumer Privacy and Data Security Rules and Guides
- Payment Card Industry Digital Security Standards (PCI-DSS)
- American Institute of CPA’s ‘SOC 2’ Guide to Service Organization Controls Relevant to Security, Availability, Processing Integrity, Confidentiality, or Privacy
- U.S. Environmental Protection Agency: Product- and chemical related adverse event recording and reporting under TSCA and FIFRA, hazardous waste classification, handling and permits, inspectional authority, reporting, company/facility registration
- U.S. CPSC (consumer product recalls, reporting)
- U.S. FTC (product advertising and marketing, telemarketing, privacy and security, reporting)
- US DOT (HazMat classification, labeling and packaging, reporting of spills on warehouse docks and during transit)
- U.S. OSHA (occupational safety, M/SDS, recordkeeping and reporting)
- Privacy and Security of protected, individually-identifiable information, reporting [US CMS/OCR (HIPAA), FTC, states, Canada]
- Labeling, Advertising and Marketing (claims, consent; U.S. FDA, EPA, FTC, states, Canada)
- Practice of Health Care (health care definitions, professional credentialing, licensure, privileging, debarment, exclusions, reporting) (US states, US FDA, US CMS, US DEA);
- State Environmental Regulations (permits, licenses, waste classification and recordkeeping, spill reporting);
- Other: U.S. Sentencing Commission’s Sentencing Guidelines for Organizations, Chapter 8; USDA, DEA, BIS, CDC, Customs, C-TPAT, Census, foreign rules which may be triggered by product composition, spills/exposure, import, export, client participation, contractual agreements, etc
- Quality Management regulations, philosophies and standards (ISO 9001, ISO 9004, ISO 13485, cGMPs, Baldrige, HACCP, AIB Guidelines, Six Sigma)
Creates and maintains a strong partnership with the client teams, both internal and external.
Other duties may be assigned.
Supervises and carries out leadership responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, retaining, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing and resolving issues. The position also requires active leadership in the way of supporting strategic initiatives as well as personal development and application of Six Sigma methodologies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Pharmaceutical and/or medical device regulatory affairs and quality assurance management experience.
U.S .FDA inspection management and auditing experience.
Excellent verbal and written communication skills.
Demonstrated excellence in problem solving and analytical skills.
Passion for customer service.
Demonstrated capability to make decisions in an uncertain environment.
Demonstrated capability to deliver effective/developmental feedback.
Ability to maintain objectivity.
Demonstrated capability for data-based decision making.
Strong organization and prioritization skills.
Results-oriented and sense of urgency.
Capability to effectively negotiate with and positively influence others.
Holds self accountable.
Fosters a culture of respect.
Risk mitigation mindset.
Must have the ability to travel as necessary and a personal credit card with an available credit limit for expenses which are reimbursed.
EDUCATION and/or EXPERIENCE
Bachelor's degree from four-year college or university is required. Five or more years U.S. pharmaceutical and/or medical device and/or biologic regulatory affairs experience required. Five or more years U.S. drug, medical device or biologic cGMP quality assurance management experience required (21 CFR 210 and 211, 21 CFR 820, and/or 21 CFR 600 and 601 and 620). U.S. FDA inspection management experience required. RAPS certification and/or ASQ certification(s), such as Biomedical Auditor, HACCP Auditor, Pharmaceutical GMP Professional, Quality Process Analyst, and Quality Auditor preferred. Business process improvement (Six Sigma certification) preferred.
Neenah, WI | Brea, CA | Fort Myers, FL | Pasig City, PH | Belize City, BZ | Mexico City, MX
- Pay Type Salary
- Neenah, WI, 120 N Commercial St, Neenah, Wisconsin, United States of America