Sr. Director Quality Affairs

Randstad USA; New Albany (OH); On-site; USD 275,000 - 285,000; Full time

Job summary

Randstad USA is seeking a Senior Director of Quality to oversee all aspects of compliance for sterile injectable production in New Albany, Ohio. You will lead cross-functional teams across laboratory operations, documentation, supplier quality, and external inspections (FDA, Health Canada) to ensure product quality and regulatory readiness.

In this role you will shape quality strategy, drive continuous improvement, manage QA operations and participate in audits with domestic and international

Qualifications

• Bachelors in Life Science or equivalent; Masters degree a plus.
• Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.
• Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations.
• Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities.

Responsibilities

• Provide leadership and direction for quality management systems, compliance, and performance goals.
• Manage regulatory inspections, customer and corporate audits, and responses.
• Oversee Quality Systems, CAPA, Deviation, Change Control, Document Control, and product release support.
• Lead on-site QA activities for production, manufacturing, filling, and transfers of sterile injectable products.

Skills

GMP

QA

Sterile Manufacturing

Regulatory Audit Prep

Education

Bachelors degree in Life Science or equivalent

Masters Degree a plus

Job description

job summary

Reporting to the Senior Director of Quality is a multi-disciplinary management role that will interact with all phases of production for the manufacture of sterile injectables. This position is responsible for oversight and direction for all aspects of compliance including laboratory operation, documentation, Regulatory Body Inspections (e.g., FDA, Health Canada, etc.), supplier quality, third party manufacturer quality, as well as strategic quality initiatives and continuous improvement processes. This position will interact with all levels of the organization both domestically and internationally.

location: New Albany, Ohio
job type: Permanent
salary: $275,000 - 285,000 per year
work hours: 9 to 5
education: Bachelors

responsibilities

Essential Duties and Responsibilities

• Provides Leadership and direction for a professional team focused on quality management systems and compliance; establish and maintain performance goals, training plans, and provide regular feedback including performance plans and reviews.
• Perform all duties in accordance withCompany's Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Quality Management Ownership for Deviation, CAPA, Change Control, Document Control, Annual Product Review Systems, Technical Services and External Manufacturers (CMO's).
• Lead Quality activities to execute production records, approve executed batch records, and support release of product for shipment.
• Manage and improve ARI's Quality Systems to ensure compliance with regulatory requirements and provide safe and effective products to customers.
• Ensures site wide cGMP compliance in accordance with 21 CFR Parts 210 and 211, USP requirements, and other regulatory requirements.
• Identify and facilitate the resolution of quality issues in conjunction with site teams.
• Manage all aspects of regulatory authority inspections, and customer and corporate audits, development of responses, and execution of required improvements following such inspections/audits.
• Own and support metrics-based Continuous Quality Improvement activities and Key Performance Indicators (KPI) through application of statistical methodology.
• Provide oversight for review and release of commercial, R&D, and clinical study products.
• Responsible for maintaining and managing communications and cross-functional activities with internal/external customers and regulatory agencies.
• Responsible for continuous improvement initiatives for the site and working with other ARI locations to assure best practices and harmonization of policies and procedures.
• Drives quality Culture and Core Competency Model initiatives in support of enhanced organizational performance.
• Responsible for Quality Control (Stability, Chemistry, Microbiology, EM, & QC Particulate labs) for the site.
• Manage and facilitate the QA Operations, QA Inspection and Finishing team to assure timely and quality oversight of production activities related to production, manufacturing, filling and transfers, inspection and packaging of sterile injectable drug products.
• Partner with Production, Regulatory Affairs, Engineering, R&D and QA Compliance to strategize and organize implementation of new technology, processes and products.
• Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues associated with daily inspections/packaging operations.
• Write and revise SOP's and other cGMP documentation.
• Ensure all work is performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

qualifications

Education Requirements and Qualifications

• Bachelors in Life Science or equivalent course of study required. Master's Degree is a plus.

• Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.

• Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations.

• Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facility.
• Understands the standards and principles of Compliance and Quality Assurance including the specific regulatory requirements and techniques of examining, questioning, evaluating and reporting to determine a quality system’s adequacy and deficiencies.
• Must have a thorough understanding of applicable regulations/guidelines/expectations and have a proven ability to apply them to a Pharmaceutical environment.
• Proven excellence in written and verbal communication skills.
• Proven record of exceptional people and program management skills.
• Ability to work independently and deliver timely results.
• Ability to work off hours and weekends as needed.
• Able to travel 10% of the time.

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

#LI-TD1

skills

skills: Good Manufacturing Practices (GMP), Quality Assurance (QA), Sterile Manufacturing, Regulatory Audit Preparation

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Education Requirements and Qualifications

• Bachelors in Life Science or equivalent course of study required. Master’s Degree is a plus.

• Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.

• Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations.

• Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facility.
• Understands the standards and principles of Compliance and Quality Assurance including the specific regulatory requirements and techniques of examining, questioning, evaluating and reporting to determine a quality system’s adequacy and deficiencies.
• Must have a thorough understanding of applicableregulations/guidelines/expectationsand have a proven ability to apply them to a Pharmaceutical environment.
• Proven excellence in written and verbal communication skills.
• Proven record of exceptional people and program management skills.
• Ability to work independently and deliver timely results.
• Ability to work off hours and weekends as needed.
• Able to travel 10% of the time.

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

Physical Environment and Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

#LI-TD1