Supervisor, Quality Assurance

Summary of role
As the Supervisor, Quality Assurance you will be accountable for driving results in a fast-paced environment by effectively managing the Quality Assurance Operations Department and associated Quality Systems and inventory Systems to ensure compliance with all regulatory requirements and company procedures. The Supervisor, drives the performance and engagement of the Quality Assurance operations team, specifically those associates that review and disposition of production records, cleaning records, raw materials, stability and reference standard packets . This leader is accountable for performing duties in accordance with Standard Operating Procedures (SOP) and driving the performance management, training and development, and continuous improvement of the team. In addition to overseeing Quality Assurance personnel, this hands-on leader will consult on quality and compliance issues and provide support during regulatory inspections. This leader will also assist with the development of SOPs or other quality improvements. The position requires superior leadership behaviours of the Sterling core values and non-negotiables, as well as expertise in functional competencies included in this position profile.
Your Responsibilities

• Ensures GMP Compliance to Regulatory requirements and Company Procedures.
• Manages Quality Systems to ensure timely closure of Observation, Deviations, Investigations, Corrective Actions, etc.
• Support and delegates SAP related actions necessary for the team
• Support cell structure and associated quality team support, adjusting as necessary
• Supports thorough Root Cause Analysis for investigations/deviations.
• Evaluates corrective and preventive actions to ensure effectiveness.
• Develops and supports team Training materials.
• Works with the QA Ops team to align and focus workload and priorities to meet client and site needs.
• Performs duties in accordance with Standard Operating Procedures (SOPs).
• Provides quality evaluation and review of MPR data.
• Maintains quality databases and may perform analysis and trending.

Requirements for the role

• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Knowledge of cGMP, SOPs, CAPAs, material controls and batch disposition procedure requirements.
• Experience with Quality systems required.
• Familiarity with Data Integrity and protecting confidential information required.
• Awareness of change management/ change control procedures preferred.
• Bachelor's degree in Chemistry, Biology, or related technical field.
• 2-5 years of related work experience required; 5-8 years preferred.
• cGMP experience required.
• Prior pharmaceutical or CDMO experience preferred.

What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.
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 organization (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, Europe and the US, where we employ more than 1300 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.
Sterling Pharma Solutions is an equal opportunity employer.