Quality Manager

Quality Manager

The Quality Manager is responsible for providing Quality leadership and support to the site. This role works closely with the Director, Quality to maintain a proactive approach to system and functional area compliance requirements. The role is a critical link between cross functional groups that include regulatory affairs, engineering, materials management, quality control, and manufacturing. The position must maintain and develop collaborative approaches to drive improvement and meet compliance. This role plays a key role in creating and maintaining a culture of quality, compliance, safety, and service. This position manages quality assurance and quality control roles at the site and acts as a mentor to team members. This position will operate independently and provide clear direction on the abilities to support projects, production, and other site level and compliance activities.

Key Responsibilities:

• Ensure personnel and work environment operate safely, ensuring EHS practices are followed.
• Develop, coach, and mentor site personnel in order to improve bench strength within the organization and create an environment of growth to improve and build on the quality culture.
• Manage the implementation and maintenance of quality assurance systems and activities, ensuring compliance to site and corporate policies, applicable regulations and providing strategic and technical input for standard and best practices for regulatory compliance. This includes oversight of the site CAPA processes and Management Review presentations.
• Lead the site supplier quality management processes, including participation in supplier selection, auditing, assessment, and investigation/corrective actions
• Manage Quality Assurance and Quality Control personnel to ensure all aspects of engineering, manufacturing operations and quality are fully supported to meet compliance and business expectations.
• Manage the generation, review, and archival of documents and records used to support current Good Manufacturing Practice.
• Lead management of and approve CAPA, complaint, investigation, audit, Change Control, and deviation systems records, ensuring timely resolution of these records to meet compliance and business expectations.
• Manage the site Quality Engineering function to facilitate effective issue investigation, root cause determination, and proposed corrective actions
• Support management of or manage quality system training program, ensuring comprehension and compliance of procedures throughout cross functional areas at the site.
• Use critical thinking skills to bring solutions to quality and technical topics such as investigations, root cause analysis, and risk management tools.
• Interface with peers at other sites to propagate best practices to:
• Write, revise, review and approve standard operating procedures and work instructions
• Develop and generate quality system metrics for tracking and trending purposes and recommend actions as appropriate.
• Make data driven and highly technical decisions that support compliance and site quality policy.
• Develop and maintain site audit programs (regulatory, external, and internal).
• Provide/review/approve information to support regulatory filings, including responses to inquiries, review of CMC, labeling review, etc.
• Participate as a leader in regulatory inspections.
• Independently lead critical compliance activities.
• May perform additional duties as required and assigned by management, including duties that support overall company initiatives.

Qualifications:

Education/Experience/Preferred Skills

• Bachelor's degree in a scientific discipline or equivalent or
• Bachelor's degree and a minimum of 8 years of experience in a cGMP environment (pharmaceuticals and medical device industries)
• At least 4 years in a Quality Assurance function within a cGMP environment with demonstrated experience in product Quality from clinical supply to commercial manufacturing, including implementation of new processes across functional groups.
• At least 5 years of supervisory/people leadership experience.

Competencies:

• Excellent interpersonal, communication and presentation skills.
• Excellent organization and project management skills.
• Strong critical thinking, problem solving and decision-making skills, with ability to trend data.
• Working knowledge of cGMPs and regulations including experience hosting or facilitating regulatory inspections.
• Experience with Design Quality Validation and Verification is preferable
• Ability to travel (5-10%).
• Robust understanding of ISO9001, ISO13485, MDSAP regulations

Organizational Relationship/Scope:

The Quality Manager collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, Engineering, and site external entities (Distribution Operations, Customer Care, Quality Compliance, etc.). The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Director, Quality. It is the expectation this position works onsite at a manufacturing facility during normal business hours M-F, but work may be performed outside normal business hours when required to support business needs.

Working Conditions:

The Quality Manager will mainly work in an office environment onsite at a manufacturing facility but may also be required to work in manufacturing and warehousing areas.