Senior Manager, Qc

10+ years

Not Disclosed

Bloomington Philadelphia Remote United States

10 Feb. 13, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:Senior Manager, QC
Location: Bloomington, United States
Job Category: Quality

The Position

Reports to: Director or above
Direct Reports: 2-12

Essential Functions

Functional Area Responsibilities:
- Responsible for all activities within the assigned functional area.
- Manage resources allocated to each functional area.
- Ensure execution of employee training plans and maintain current training documentation.
- Identify, maintain, and report functional KPIs to site management.
- Monitor and report project milestone completion and timing.
- Accountable for revenue reporting and billing.
Continuous Improvement:
- Drive continuous improvement by leading cross-functional teams to address:
  - Process improvement
  - System improvements
  - New regulations/expectations
  - New business needs
  - Training improvements
  - KPI performance improvements
Safety & Compliance:
- Maintain a safe and healthy work environment by enforcing organizational standards and adhering to legal regulations.
- Review and approve data and reports.
- Conduct performance reviews and engage in the hiring process for employees.
Collaboration & Leadership:
- Regularly participate in customer team meetings.
- Assist in customer audits and regulatory inspections.
- Provide technical assistance to team members.
- Lead team members to improve and reinforce performance.
- Set clear goals and expectations for direct reports, track progress, and address performance concerns.
- Coach and support direct reports in their career development.
Other Duties:
- Perform other duties as assigned by leadership.

Microbiology Responsibilities

Daily Operations:
- Ensure compliance with Quality standards and project timelines, including execution of work and coordination with stakeholders.
- Collaborate with internal Catalent stakeholders to complete microbiological analyses and ensure efficient processes.
- Oversee microbiological compendial method verification.
- Supervise qPCR/PCR method development, qualification, validation, and execution.
- Oversee the site’s environmental monitoring program and collaborate on environmental testing.
- Trend and report site environmental monitoring data.
Instrument Maintenance:
- Support instrument onboarding and maintenance.

Stability Responsibilities

Stability Testing & Reporting:
- Ensure adherence to Quality standards and timelines for stability testing.
- Manage sample management team and oversee the stability protocol creation and testing processes.
- Collaborate with internal stakeholders to complete stability analyses, reports, and ensure proper test directives.
Reporting & Monitoring:
- Monitor stability protocol creation, sample pulls, testing, and report issuance.

Release and In-Process Responsibilities

Release Testing:
- Ensure compliance with Quality standards and timelines for release and in-process testing.
- Collaborate with internal stakeholders to complete analyses, reports, and maintain efficient processes.
- Oversee the completion of Certificates of Analysis and contract testing laboratories.
Data Review:
- Perform Quality Control data review for routine testing and support instrument maintenance.

Method Validation Responsibilities

Method Validation & Qualification:
- Oversee method validation and qualification work, coordinating with stakeholders and maintaining efficient processes.
- Ensure completion of method qualification/validation protocols and reports.
- Provide analytical method expertise within the department.

Physical Requirements

Physical Demands:
- Frequent sitting, standing, walking, reading of written documents, and use of computer monitor.
- Occasional stooping, kneeling, bending, carrying, grasping.
- Frequent lifting/moving up to 10 pounds and occasional lifting/moving up to 50 pounds.
- Must comply with Environmental, Health, and Safety (EHS) responsibilities for the position.
- Working conditions will be controlled (heating, ventilation, and air conditioning).

Qualifications

Education/Experience:

Bachelor’s degree in life sciences required, with at least 2 years of laboratory experience or an equivalent background.
10 years of GMP experience or in another regulated industry.
5-8 years of management experience.
Must be able to read and understand English-written job instructions and safety requirements.

Technical Requirements:

Excellent written and verbal communication skills.
Ability to lead complex technical discussions with customers and subordinates.
Experience in ensuring compliance with company SOPs, cGMP, ICH, FDA, EMA regulations or guidelines.
Expertise in regulatory and client audits as a Subject Matter Expert.
Ability to combine and interpret data from multiple disciplines.

Behavioral Requirements:

Excellent interpersonal communication skills.
Skilled at negotiating and persuading others.
Ability to anticipate reactions and effectively manage diverse stakeholder expectations.
Strong organizational skills, with the ability to handle multiple activities simultaneously.
Ability to work effectively under pressure with multiple deadlines.
Demonstrates a positive attitude and cooperates within a team environment.

Leadership Requirements

Project Leadership:
- Lead projects within a department, group, or team using knowledge of applicable principles and techniques.
- Apply technical and functional knowledge to design impactful projects and improvements.
- Coordinate strategic or continuous improvement activities within and across teams.
- Set clear objectives aligned with site goals and manage resource allocation.
Employee Development & Performance:
- Clarify responsibilities and expectations while holding employees accountable.
- Participate in HR-related processes and provide constructive feedback.
- Use coaching and flexible interpersonal methods to develop others’ capabilities.
- Collaborate with direct reports to set meaningful performance objectives.

Commitment to Diversity & Inclusion

At Novo Nordisk, we aspire to be the best company for the world, valuing diverse perspectives, backgrounds, and cultures. We are committed to creating an inclusive environment that celebrates our employees, the patients we serve, and the communities we operate in.

Novo Nordisk is an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

If you need assistance or an accommodation to apply, please contact us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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