Manager Sample Management and Planning Quality Control
WuXi AppTec
**Overview**
Quality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site's Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product's Dossier managed by the Customer.
This position is responsible, with its multitasking team, to support QC for commercial activities like qualification of new equipment, master data management, audit trail review and adherence with data integrity principles.
As a QC Management team member, the position holder is collaborating with the other QC people managers to ensure that the testing methods, processes, and techniques are maintained and improved and that any cGMP/GLP compliance issues is duly addressed in a timely manner.
**Responsibilities**
**Essential Job Functions:**
+ Builds and leads a team assuring that adequate staff, organization, equipment and facilities are available to complete the assigned tasks.
+ Assigns tasks to direct reports in accordance with their responsibilities and capabilities. Ensures continuous professional development and guidance to direct reports.
+ Assigns tasks to direct reports to ensure :
+ initial instrument qualification,
+ master data management and audit trail review of computerized systems,
+ adherence with data integrity principles
+ Responsible for resolution of process and protocol deviations, assuring effective root cause identification and corrective/preventive actions to of any deficiencies linked to lab equipment
+ Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility
+ Works closely with EHS to evaluate hazards and perform risk analysis
+ Promotes safe practices and behaviors, verify that EHS rules are implemented and followed
**Qualifications**
**Job Requirements:**
**Experience / Education**
+ At least 5 years of experience in Quality Control in a pharmaceutical company or other related industry.
+ Minimum CFC degree in scientific Laboratory or related science.
**Knowledge / Skills / Abilities:**
+ Thorough understanding of cGMPs, GLP, and EU, Swiss, and FDA regulatory requirements.
+ Solid understanding of Oral Solid Dosage form manufacturing, packaging, warehousing processes and associated analytical and microbiological testing, sampling techniques and overall laboratory and samples workflows.
+ Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.
+ Excellent interpersonal, collaborative and organizational skills.
+ Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.
+ High credibility and reliability.
+ Excellent investigational and problem solving skills.
+ Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.
+ Drives continuous improvement.
+ Knowledge of most common office software and of IT-principles.
+ Capability to evaluate, investigate and solve problems related to qualification and master data management
**Leadership Activities: (only for people manager roles)**
+ Responsible for supervision/training of Operators (Junior, Senior, Lead) —previous supervisory experience not required, but is a plus.
+ Must be able to work unsupervised, and along with operators/engineers.
+ Must be able to organize and lead training sessions on new equipment or procedures.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
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**Job Locations** _CH_
**Job ID** _2025-13488_
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