Mqa Manager

Nexus employees earn 4 weeks' vacation per year, and our benefits start on day 1!
Title: MQA (Manufacturing Quality Assurance) Manager
Full Time
Location: Pleasant Prairie, WI
Our Company
Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they are needed most.
Position Summary
The Manufacturing Quality Assurance (MQA) Manager will focus on the company's quality standards, manufacturing processes and testing systems to reflect efficiency, reliability, and the highest quality performance. MQA Manager must be familiar with applicable cGMP regulations and systems and can make decisions based on those requirements. This individual will be responsible for providing Quality Engineering guidance through validation of manufacturing processes, recommendation and implementation of process improvements, quality data analysis, and employing effective corrective actions for continuous improvement solutions. The candidate will be hired at the appropriate level commensurate with education and years of required relevant experience.
Role Responsibilities:

• Manage MQA Associates, Technical Writers, Inspectors, and Technicians.
• Provide quality oversight/review/approvals of process validation studies (e.g., product, cleaning, sterilization, media fills).
• Establish Standard Operating Procedures and Policies.
• Perform investigation of product nonconformances, conduct root cause analysis in accordance with internal procedures.
• Create, generate, analyze, and report quality metrics throughout all levels of the organization to drive continuous improvement by using statistical tool methodology. In addition, must demonstrate the ability to apply statistical tools to define sampling strategies (i.e., six-sigma, etc.).
• Support Quality Systems group by developing and administering Quality Assurance training.
• Review and approve protocols for process validation, incorporating design elements, execution of product validation and subsequent continuous process verification.
• Lead cross-functional teams to address and resolve quality issues; ensure appropriate training, processes and equipment are in place for all manufactured products.
• Create/execute/review/approve risk assessment, validation protocols, quality protocols, standard operating procedures as needed.
• Create, review, and approve change control requests.
• Oversee management of change (engineering/design change)
• Create, review, and approve Master Batch Production Records.
• Lead FDA inspection readiness activities.
• Host FDA regulatory inspections.
• Write responses to regulatory audit findings.
• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
• Represent the quality team and make appropriate recommendations internal and external to the organization for continuous improvement and problem resolution.
• Experience working with cross-functional groups such as planning, manufacturing, packaging, and distribution to ensure proper priorities are set and necessary activities are planned to meet these goals.
• Mentor and coach MQA employees.
• Other duties as assigned.

Requirements
Skills and Abilities:

• Excellent verbal and written communication skills to all levels of the organization.
• Technical writing required.
• Strong experience working in cross-functional team. Ability to influence, negotiate, manage conflict, and collaborate.
• Must be a strategic, innovative driver of technical solutions, quality implementation, risk management and change with strong technical skills.
• Required to exercise good judgement as errors may cause moderately serious delays, confusion and could affect company reputation and/or customer relations.
• Must effectively work with different departments and communicate with all levels of management.

Experience and Education:

• Bachelor's degree in a science or business discipline is required
• Minimum of 10 years of relevant work experience in a FDA regulated manufacturing environment (quality, manufacturing, validation)
• Experience in an aseptically fill/finish operations preferred, FDA regulated manufacturing environment - cGMP pharma experience required.
• Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
• Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively
• Previous experience presenting and defending QMS documents with regulatory agencies required.
• Previous experience with review of quality, validation, engineering related documentation and batch documentation required for regulatory submissions and product release.

Travel Requirements:

• 5-25% Travel required for this role (domestic and international)

Physical Demands:

• Lifting requirements less than 50 pounds.
• Sitting 85% of day.
• Office and Laboratory Environment

Level of Proficiency:

• Must be able to work independently.
• Strong organizational skills
• Ability to set long-term goals and objectives.

DISCLAIMER: The list under Role Responsibilities is not exhaustive but is merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.
EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.