Manager, Quality Control

Job Description

The Manager, Quality Control will oversee the responsibilities of the QC Microbiology group including the EM/UM programs as well as routine testing and contamination response; develop team members and career paths; implement best industry practices; lead and participates in projects internally and cross-site/cross-departmentally. Ensure team is aligned with goals, objectives. Conduct performance evaluations for subordinates and ensure that employees are trained. Additional responsibilities include scheduling/balancing of team workload with respect to assignments, responsibilities, personnel, management of departmental milestones. Accountable for approval of technical documents for team. Maintain tracking of workload and processes for team to ensure optimization and delivery. Responsible for ensuring GMP compliance, and alignment with quality systems. Responsible for applying that knowledge in coaching and continuous improvements of systems cross-functionally.

What You’ll Do

· Oversee team deliverables and sustainability with timely communication for priorities

·Properly escalateissues to senior QC management as applicable

· Track& reportprogress to tasks and departmental metrics to upper management, as applicable

· Effectively problem solve and reallocate resources as necessary

· Provide leadership for QC initiatives as related to scientific, technical discipline, business strategy- global improvements

· Lead complex projects and initiatives

· Manage activities including; technical writing, project representation that are complex and/or those with significant impact (routine or minimal complexity)

· Hire and develop a well-functioning team – focusing on values and culture

· Ensure establishment of goals and development plans for employees. Ensure effective team training for group activities, responsibilities and performs performance reviews.

· Coordinateactivities with other departments; provide updates to QC team mgmt.

· Routinely collaborate with Manufacturing, Engineering, Quality Assurance, PQM, Regulatory, TD, Validation, AT, cross site stakeholders etc.

· Provide microbial awareness and aseptic technique training in collaboration with site functions

Who You Are

You love collaborating cross functionally to determine root cause and potential corrective actions.You enjoy motivating and developing a team to meet or exceed goals.


Required Skills

· Bachelors or Masters Degree in science

· 7+ years of experience in GMP laboratory role/support role

· 4+ years of leadership experience in comparable role, experience with regulations, FDA/MHRA

· Can effectively lead change & complete initiatives aligned with the business

· Ability to flex and respond to unexpected situations, demands

Preferred Skills

· Aseptic Technique/Processing, Environmental monitoring/Utility monitoring, microbial identification, bioburden, endotoxin, growth promotion, USP, EP, JP compendia

Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.