Quality Compliance Lead

Company Description

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Job Description

The Quality Compliance Lead will be responsible for executing and tracking improvements in the quality compliance activities and status required within the site operations to comply with cGMP and customer expectations related to active pharmaceutical ingredient manufacturing, with a major emphasis on real-time inspection readiness and quality metrics reporting.

This role will also assist with regulatory agency and client audits, and prepare the response and monitor the implementation of any preventative and corrective actions. The Quality Compliance Lead must have a thorough understanding of ICH guidance, FDA regulations, GMPs, and Quality Systems relevant to the manufacturing of pharmaceuticals.

Key Responsibilities / Accountabilities

• Lead the real-time inspection readiness programs at the site through design and execution of efficient, effective internal audits and compliance monitoring programs, including conducting and overseeing auditing activities.
• Lead GMP, and quality risk gap analyses, create and lead action plan teams.
• Perform Quality Risk Management assessments and support other departments during risk analysis assuring the inclusion of patient safety risk and customer concerns.
• Assist in customer complaint investigations and engagement with customer as needed for resolution.
• Assist in creation of GMP training program to include customer and agency inspection feedback
• Create implementation plans to address revisions in GMP regulations, ICH guidance and customer expectations.
• Review documentation for IOQ, periodic review as well as commissioning and decommissioning of production equipment and/or laboratory instruments.
• Manage the quality metrics monthly reporting to the global management team and create specific metrics monitoring plans to measure compliance program effectiveness.
• Assist customer quality audits, including audit responses and share voice of customer with extended compliance systems peers from other sites.
• Monitor audit observations, CAPA and investigations for trends, work across sites to create action plans which can be implemented across the sector.
• Monitor the Supplier Quality Management program for service and material suppliers, including Supplier Qualification, risk assessments, performance management, and quality agreements
• Aid in the harmonization and maintenance of harmonization of the Quality Management Systems across sites, updating procedures, decision trees and compliance tools for the site, as needed.
• Manage receipt and distribution of directives, regulations, and inspection reports from regulatory agencies.
• Participate FDA inspections, audits, and inspections by other regulatory agencies.
• Educate staff on Quality practices, including new hire quality orientation and compliance training.
• Other duties as assigned.

Quality/Regulatory Responsibilities

• Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance's, FDA regulations, etc.
• Provides technical expertise to all departments when developing quality policies and procedures.
• Ensures site quality policies and procedures are compliant with state and federal requirements, including but not limited to GMP, DEA, FDA, etc.
• Responsible for leading efforts for audit readiness and ensuring appropriate staff are available to participate in quality audits with the FDA, other Regulatory Agencies and customers.
• Provides guidance to all departments on quality-related issues.

Environmental, Health and Safety Responsibilities

• Manages staff in full compliance with all appropriate EH&S policies and procedures.
• Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers.
• Ensures staff acts in accordance with EH&S policies, practices and procedures.
• Addresses staff issues accordingly if there are EH&S violations.
• Actively participates in root cause investigations on near misses and all incidents. Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department.
• Demonstrated technical and procedural expertise and self-assuredness in applying EH&S policies and procedures.

Physical Demands and Work Environment

• Predominately in office environment. Occasional walking, standing for long periods of time while in labs/plant, kneeling, reaching, handling, twisting, and bending spine at waist when filing or operating office/lab equipment.
• May be exposed to odors, noise, heat, and toxic or caustic chemicals when in labs/plant

Qualifications

Required

• BS in Chemistry or equivalent
• Minimum 5 years of experience within a Quality function for an FDA/EMA/MHRA regulated industry
• Have previous experience auditing for cGMP compliance
• Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
• Experience working in global, cross-functional teams for project execution
• Experience creating metrics for driving continuous improvement
• Experience with drug substance or product manufacturing
• Able to successfully interface with internal and external customers
• Excellent analytical, written and verbal communication and presentation skills
• Strong technical writing skills and the ability to clearly express ideas in English
• Ability to work independently and in a team environment
• Experience with Microsoft Office applications, including Word, Excel and PowerPoint at a minimum
• Expertise in FDA regulations, EU GMP, ICH Q7 and Part 11 compliance

Preferred

• Experience in an Active Pharmaceutical Ingredient manufacturing environment
• Experience in applying and implementing GMP concepts in association with bringing a product through validation to commercialization

Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.