CDMO, CMO, Contract Development and Manufacturing Organisation

Senior Manager, Quality Assurance

Job Title
Senior Manager, Quality Assurance
Location
Germantown,  WI 53022
Other Location
Description

Summary of Role
The Senior Manager, Quality Assurance is an adaptable professional accountable for driving team and organizational results in a fast-paced expanding business environment. Key areas of focus are establishing and maintaining compliant and robust quality systems, leading and driving continuous quality improvement initiatives, leading and coaching a team of quality specialists to ensure on time releases, ensuring the utmost in customer satisfaction, troubleshooting quality events and serving as a subject matter expert in Quality System elements.  The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

  • Understands and applies GMP principles to the manufacturing and oversight of Active Pharmaceutical Ingredients (API) following global regulations.
  • Works with site management and peers to lead Quality and Compliance.
  • Manages and oversees the daily activities of the Quality Assurance Unit.
  • Tracks and manages unit performance against site metrics.
  • Manages Quality Systems to ensure timely closure of Deviations, Investigations, Corrective Actions, etc.
  • Identifies and implements action plans to mitigate risks and drive continuous improvement.
  • Reviews and approves Standard Operating Procedures, Master Production Records (if necessary) and Specification Test Records.
  • Reviews batch production records.
  • Reviews and approves validation protocols and reports.
  • Collaborates with various departments and facilitates facility and cGMP training as necessary.
  • Serves as a Quality contact for clients.
  • Performs Quality System reviews as required.
  • Communicates compliance concerns to Director/Departmental Managers/President.
  • Proactively works to improve quality systems and enhance overall quality.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Fosters and develops staff through work assignment and establishing of stretch goals, with a focus on individual growth and planning for future needs of the organization.
  • Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Education and Experience

  • Bachelor’s degree in Chemical Engineering or related field.
  • 10+ year of industry related experience, including 3+ years supervisory experience plus either 2+ years of project management or 2+ years of management level experience.

Key Competencies

  • Strong knowledge of Quality Systems.
  • Working knowledge of cGMP in a pharmaceutical or regulated environment.
  • Working knowledge of FDA and ICH-Q7.
  • Strong technical writing and critical thinking skills.
  • Excellent verbal and written communication skills.
  • Excellent presentation skills.
  • Directly leads team of approximately 8 - 10 direct reports.
  • Indirectly leads team of approximately 3 - 5.
  • Must be very organized as position has quality oversight for up to 20 customer programs at one time.
  • Involved and participates in Regulatory and Customer Audits.
  • Strong understanding of validation and change control.
  • Participates in the hiring process of other employees.
  • Schedules and reviews the work of other employees.
  • Determines methods and procedures to accomplish business requirements, including new assignments and the work of others.
  • Ensures accuracy and relevance of assigned training curriculum for direct and indirect reports.
  • Drives timely completion of training for direct and indirect employees to meet regulatory requirements.
  • Coaches, mentors and develops other employees.
  • Prepares and delivers performance evaluations of other employees.
  • Makes recommendation of disciplinary actions of other employees.
  • Uses professional concepts and company policies and SOPs to solve a variety of problems.
  • Proficiency with Microsoft Office Software (Word, Excel, PowerPoint).
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
  • Duties, responsibilities and activities may change at any time with or without notice. 

Diversity and Inclusion

Sterling values diversity and we are committed to creating an inclusive environment for all employees.  All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

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