Job Description
The Life Science Senior Quality Manager is responsible for all aspects of Quality Assurance including but not limited to : compliance with applicable regulations and standards, assist in post market surveillance activities and continuously monitoring the organization identifying opportunities for improvement and alignment.
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq : COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.
Responsibilities
- Responsible for day-to-day oversight of the following Harmonized Quality Management System :
Quality Events (Deviations, Nonconformance, Change Control and Corrective and Preventive Action)
Complaint handling, monitoring and resolutionSupplier QualityDocument Control, Records Management, and Document TrainingAdverse event reporting
Continuous Improvement : Identifying areas for improvement in validation and compliance processes and implementing corrective actions. Develop, implement, maintain, and continually assess the Company's QC function and Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external global regulatory requirements.Develop, implement, maintain, and continually assess the Company's QC function and Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external global regulatory requirements.Training and Development : Designing and implementing training programs for staff Quality Assurance Team members for the day-to-day management. Additionally creating and implementing a training program for organizational staff to ensure understanding of the Quality Management System and process for compliance.Responsible for day-to-day oversight of the following Quality Control System :Validation and equipment
Responsible for ensuring that all manufacturing equipment, processes, and documentation meet regulatory standards and demonstrate suitability.
Training and Development : Designing and implementing training programs for staff on validation and compliance procedures.Reagent Quality Control :Lead investigations and resolution of findings impacting the product identified through audits, non-conformances, corrective / preventive actions, or customer complaint escalations.Leads and participates in cross-departmental / organizational teams. Accountable for quality control support of new product integration, stability program, process development, equipment and process validations, as well as meeting production schedules.Metric Reporting Program :Establish, manage, track, trend and deliver timely reporting of departmental performance metrics and statistical process controls; drive actions as required.
Audit and Inspection Support : Supporting internal and external audits and inspections to ensure compliance with regulatory standards.Project Management : Lead or participate in sustaining projects for improvement of processes, global harmonization, infrastructure, product specifications, process / test methods, analysis tools, and business systems.Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.Lead the implementation of a robust Quality System that will ensure premium patient care delivering internal and external customer satisfaction.Manage and coordinate all aspects of quality working at all levels of the organization as necessary to implement policies and procedures necessary for quality requirements.Represent and own quality corporate functions including, but not limited to : Management Review, Core Team member on projects and inspection response (internal and external)Assists in implementation of regulatory changes impacting quality systems and support for quality.Knowledge of Risk Management principles including the use of risk management techniquesEstablish and implement consistent metrics for monitoring system effectiveness to enable Quality customers to make sound quality decisions and drive continuous improvement.Clearly communicate quality issues, identified risks, continuous improvements opportunities and corrective actions throughout affected departments and leadership teamsOwner of metric review and actively identifies opportunities for improvements in collaboration with Quality Assurance CustomersPerforming compliance review and approval on executed records for completeness of all required testing, verification of documents for various processesDemonstrates understanding of external and internal quality system regulations to adopt best in class / processes and drive continuous improvement initiatives.Perform other Quality Assurance tasks as required.Supervisory Duties :
Lead and coach individuals within the Quality Team. Conduct ongoing performance acceleration / evaluation assessment and provide feedback to employees in order to help optimize their and the teams overall performanceMentor the team and actively identifies professional development opportunities.Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Proactively mentor, coach and provide resources for personnel professional development.LI_CN1
Qualifications
Qualifications
Knowledge, Skills and Abilities
Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.Familiarity or experience with the following is strongly preferred : Basic statistics, review / approval of documentation; risk tools, technical writing, and writing / reviewing / approving investigations.Computer Skills :
Knowledge of Master Control, or similar eQMS a plusDemonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.Adaptability
Responds effectively to changing constraints.Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.Understands the drivers of change and anticipates the implications of changing political and practical circumstancesApplies a preventative instead of corrective approach Attention to DetailChecks information, picks up inconsistencies and mistakes and can make detailed comparisons between similar sourcesPositive work attitude that supports teamwork and continuous improvement.Decision Making
Makes pragmatic decisions based on range of factorsAble to make decisions quickly where necessary, based on incomplete informationDemonstrates logic to back up decisionsExcellent critical analytical skills - ability to find root cause of why and issue occurred.Initiative
Identifies ways to improve processes / situationsTakes responsibility for improvements or solving problems.Must display eagerness to learn and continuously improve.Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities Interpersonal SkillsSocially capable - interacts confidently, reads the situationEmpathetic and can evaluate likely reactionsCollaborative approachResults Oriented
Ability to focus on important issues only. Risk based approachRegularly refocuses on resultsDemonstrates a drive to exceed performance targetsTask Management
Ability to handle multiple tasks and competing priorities concurrently and in a timely fashionPrioritizes and monitors tasks progressMakes realistic estimates of time and resource requirementsWork Environment :
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision.Education :
Bachelor's Degree in Science or a related discipline preferredFive (5) to seven (7) years equivalent experience and / or trainingor Associates degree (A.A.) with eight (8) to ten (10) years related experience and / or training; or equivalent combination of education and experience.Experience
Quality Assurance Senior Manager has shown proficiency in Quality Management System Management role.Candidate should demonstrate knowledge of regulations and standards such as :CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards : ISO 15189 Medical Laboratories
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies : Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms / employment agencies to any employee at CooperSurgical via-email, the internet or in any form and / or method will be deemed the sole property of CooperSurgical, unless such search firms / employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace
