Senior quality assurance manager job description
Updated March 14, 2024
13 min read
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Example senior quality assurance manager requirements on a job description
Senior quality assurance manager requirements can be divided into technical requirements and required soft skills. The lists below show the most common requirements included in senior quality assurance manager job postings.
Sample senior quality assurance manager requirements
- Minimum 7 years of experience in Quality Assurance
- Bachelor’s degree in a relevant field
- Strong knowledge of quality control and assurance methodologies
- Experience with quality management systems
- Experience with regulatory requirements
Sample required senior quality assurance manager soft skills
- Excellent communication skills
- Leadership and team management skills
- Ability to work under pressure and meet deadlines
- Problem-solving and decision-making skills
- Attention to detail and accuracy
Senior quality assurance manager job description example 1
CSG senior quality assurance manager job description
24143 Senior Manager QA Testing (Open)
Position Type:
Full time
Location(s):
ZA.Centurion.OfficeZA.Cape
Town.Office, ZA.Cape Town.Remote, ZA.Centurion.Remote, ZA.Durban.Remote,
ZA.Johannesburg.Client
Position Details:
CSG is a leader in innovative customer engagement, revenue management, and payments solutions that make ordinary customer experiences extraordinary.As a flexible first organization, you can find our remote and on-site locations here.
Hi, I'm Genevieve Moodley, your Recruiter. At CSG, we choose to see beyond a resume paper. We put your story, perspective, background, and what you have to offer first. While the traditional approach works for some, many miss out on fantastic talent like yourself, and we refuse to make that mistake. Instead, we believe that by channeling the power of all, we make ordinary customer and employee experiences extraordinary.
Channel the power of YOU as the next Full-Time Senior Test Manager at CSG.
Who will love this job
A hybrid - you excel when you can choose your work style - remote, in-office, or a combination of bothA strategist - you have a consulting mindset that allows others to contribute and work toward a shared visionA collaborator - you love to work on projects that have functional workflowsA producer - you're comfortable quickly switching context and adapting An empath - you know how to connect and communicate with different audiences worldwide
What you'll do
You will report to the Regional Director Solution Delivery to contribute towards the management of CSG test teams, partner teams, partnering with senior customer management and CSG management on planning and status reporting.You will manage all test activities for the E2E solution.You'll provide input to the Project Quality Plan; reviews and approve the Plan to ensure it meets the defined standards and outputs.You will provide consultation to Test Leads, Project Managers on test estimations, testing strategy, test creation and results around Testing activities.You will ensure test entry/exit criteria are identified, agreed and fulfilled for System Integration Testing and within project and test targets.You will ensure the necessary tools are available for the testing team and ensure the appropriate planning and management of the test resources for the team.
You should have
Research shows that candidates from underrepresented backgrounds often don't apply for roles if they don't meet all the criteria - unlike majority candidates meeting fewer requirements. Channel the power of YOU and apply to discover if we're a match.
Bachelor's degree in a related field, or equivalent experience.10 years testing experience, with 7 years in test leadership experience in large implementation/software development projects.Experience of procedures in QA, automation and end-to-end Software Testing.Experience leading test strategy and approach, with in-depth understanding of test processes and methodologies.Experience in a distributive software environment and application testing with a multifaceted team.Experience in a consulting environment, with client contact.
Our Story
For over 40 years, we've serviced the world's most recognizable brands with future-ready solutions in customer engagement, revenue management, and payments that make ordinary customer experiences extraordinary. As a trusted technology provider in telecommunications, retail, financial services, and healthcare, our solutions impact over 900 customers in over 120 countries. Over 5,000 customer-obsessed CSGers in more than 20 countries made it possible and helped reach our $1 billion in revenue milestone.
Our Way of Life
Our people power a culture of integrity, innovation, and impact. In return, we power our people with the choice to work from home, in-office, or a hybrid work combination that integrates well with their lifestyle. You'll find CSGers exercising this choice at most of our locations worldwide.
We are committed to building and nurturing a diverse, supportive, and inclusive work environment where individuality is valued, and our people can flourish. We believe our workforce should reflect the world we live in and that we are stronger because of our differences. By embracing different backgrounds, attributes, experiences, and perspectives, we will help our employees, customers, and communities excel while, together, we work toward making social equality a reality.
We are committed to making a bigger community impact by creating new opportunities and access for underrepresented communities, protecting the environment, and developing technology solutions that foster digital inclusivity. That's just who we are. If not us, then who?
Follow us! LinkedIn | Facebook | Twitter
Position Type:
Full time
Location(s):
ZA.Centurion.OfficeZA.Cape
Town.Office, ZA.Cape Town.Remote, ZA.Centurion.Remote, ZA.Durban.Remote,
ZA.Johannesburg.Client
Position Details:
CSG is a leader in innovative customer engagement, revenue management, and payments solutions that make ordinary customer experiences extraordinary.As a flexible first organization, you can find our remote and on-site locations here.
Hi, I'm Genevieve Moodley, your Recruiter. At CSG, we choose to see beyond a resume paper. We put your story, perspective, background, and what you have to offer first. While the traditional approach works for some, many miss out on fantastic talent like yourself, and we refuse to make that mistake. Instead, we believe that by channeling the power of all, we make ordinary customer and employee experiences extraordinary.
Channel the power of YOU as the next Full-Time Senior Test Manager at CSG.
Who will love this job
A hybrid - you excel when you can choose your work style - remote, in-office, or a combination of bothA strategist - you have a consulting mindset that allows others to contribute and work toward a shared visionA collaborator - you love to work on projects that have functional workflowsA producer - you're comfortable quickly switching context and adapting An empath - you know how to connect and communicate with different audiences worldwide
What you'll do
You will report to the Regional Director Solution Delivery to contribute towards the management of CSG test teams, partner teams, partnering with senior customer management and CSG management on planning and status reporting.You will manage all test activities for the E2E solution.You'll provide input to the Project Quality Plan; reviews and approve the Plan to ensure it meets the defined standards and outputs.You will provide consultation to Test Leads, Project Managers on test estimations, testing strategy, test creation and results around Testing activities.You will ensure test entry/exit criteria are identified, agreed and fulfilled for System Integration Testing and within project and test targets.You will ensure the necessary tools are available for the testing team and ensure the appropriate planning and management of the test resources for the team.
You should have
Research shows that candidates from underrepresented backgrounds often don't apply for roles if they don't meet all the criteria - unlike majority candidates meeting fewer requirements. Channel the power of YOU and apply to discover if we're a match.
Bachelor's degree in a related field, or equivalent experience.10 years testing experience, with 7 years in test leadership experience in large implementation/software development projects.Experience of procedures in QA, automation and end-to-end Software Testing.Experience leading test strategy and approach, with in-depth understanding of test processes and methodologies.Experience in a distributive software environment and application testing with a multifaceted team.Experience in a consulting environment, with client contact.
Our Story
For over 40 years, we've serviced the world's most recognizable brands with future-ready solutions in customer engagement, revenue management, and payments that make ordinary customer experiences extraordinary. As a trusted technology provider in telecommunications, retail, financial services, and healthcare, our solutions impact over 900 customers in over 120 countries. Over 5,000 customer-obsessed CSGers in more than 20 countries made it possible and helped reach our $1 billion in revenue milestone.
Our Way of Life
Our people power a culture of integrity, innovation, and impact. In return, we power our people with the choice to work from home, in-office, or a hybrid work combination that integrates well with their lifestyle. You'll find CSGers exercising this choice at most of our locations worldwide.
We are committed to building and nurturing a diverse, supportive, and inclusive work environment where individuality is valued, and our people can flourish. We believe our workforce should reflect the world we live in and that we are stronger because of our differences. By embracing different backgrounds, attributes, experiences, and perspectives, we will help our employees, customers, and communities excel while, together, we work toward making social equality a reality.
We are committed to making a bigger community impact by creating new opportunities and access for underrepresented communities, protecting the environment, and developing technology solutions that foster digital inclusivity. That's just who we are. If not us, then who?
Follow us! LinkedIn | Facebook | Twitter
Post a job for free, promote it for a fee
Senior quality assurance manager job description example 2
Gillette senior quality assurance manager job description
P&G is the largest consumer packaged goods company in the world. We have operations in over 75 countries with 65 trusted brands that improve the lives of 5 billion consumers worldwide. This brings many advantages, including the opportunity for our employees to enjoy a diverse and rewarding lifelong career filled with new and exciting challenges.
Are you looking for a position that offers a rewarding lifelong career filled with new and exciting challenges? P&G is looking for a Quality Assurance Senior Manager.
The Quality Assurance Senior Manager has responsibility for the development, implementation, monitoring and improvement of site quality systems related to procedures, and standards, KPIs, continuous improvement, capability and development of the Beauty organization. Has direct responsibility for the management of on-site Quality Assurance personnel and product disposition recommendations. A point of contact for external and internal audits supporting front room and leading backroom excellence for external and internal QA assessments. Systems include delivering and sustaining cGMPs, consumer comments, learning and development, investigations, micro clean design and validations.
Job Qualifications
You're a good fit if:
+ You have at minimum Bachelors degree in Engineering or Physical Sciences (Chemistry, Microbiology, etc...)
+ You have 5+ years of QA experience with industrial, manufacturing operations, pharmaceutical domain preferred.
+ Experience working with the FDA, CFIA, and / or other external regulatory agencies for audit purposes
+ Experience serving as point of contact for internal audits
+ You have proven cGMP capability of implementation
+ You have strong leadership to implement culture changes and adherence to standards
+ You have demonstrated leadership and communication skills both verbal and written at an individual level and team.
Just so you know:
We are committed to providing equal opportunities in employment. We value diversity and do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age marital status, veteran status or disability status.
Immigration sponsorship is not available for this position, except in rare situations based on Procter and gamble's sole discretion. Applicants for U.S. based positions are eligible to work in the U.S. without the need for current or future sponsorship. We do not sponsor permanent residency. Any exceptions are based on the Company's specific business needs at the time and place of recruitment as well as the particular qualifications of the individual.
Procter and Gamble participates in e-verify as required by law.
Qualified individuals will not be disadvantaged based on being unemployed.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Job Schedule
Full time
R000057252
Job Segmentation
Experienced Professionals (Job Segmentation)
Are you looking for a position that offers a rewarding lifelong career filled with new and exciting challenges? P&G is looking for a Quality Assurance Senior Manager.
The Quality Assurance Senior Manager has responsibility for the development, implementation, monitoring and improvement of site quality systems related to procedures, and standards, KPIs, continuous improvement, capability and development of the Beauty organization. Has direct responsibility for the management of on-site Quality Assurance personnel and product disposition recommendations. A point of contact for external and internal audits supporting front room and leading backroom excellence for external and internal QA assessments. Systems include delivering and sustaining cGMPs, consumer comments, learning and development, investigations, micro clean design and validations.
Job Qualifications
You're a good fit if:
+ You have at minimum Bachelors degree in Engineering or Physical Sciences (Chemistry, Microbiology, etc...)
+ You have 5+ years of QA experience with industrial, manufacturing operations, pharmaceutical domain preferred.
+ Experience working with the FDA, CFIA, and / or other external regulatory agencies for audit purposes
+ Experience serving as point of contact for internal audits
+ You have proven cGMP capability of implementation
+ You have strong leadership to implement culture changes and adherence to standards
+ You have demonstrated leadership and communication skills both verbal and written at an individual level and team.
Just so you know:
We are committed to providing equal opportunities in employment. We value diversity and do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age marital status, veteran status or disability status.
Immigration sponsorship is not available for this position, except in rare situations based on Procter and gamble's sole discretion. Applicants for U.S. based positions are eligible to work in the U.S. without the need for current or future sponsorship. We do not sponsor permanent residency. Any exceptions are based on the Company's specific business needs at the time and place of recruitment as well as the particular qualifications of the individual.
Procter and Gamble participates in e-verify as required by law.
Qualified individuals will not be disadvantaged based on being unemployed.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Job Schedule
Full time
R000057252
Job Segmentation
Experienced Professionals (Job Segmentation)
Dealing with hard-to-fill positions? Let us help.
Senior quality assurance manager job description example 3
Mallinckrodt senior quality assurance manager job description
Job Title
Senior Manager Quality Assurance
Requisition
JR000011845 Senior Manager Quality Assurance (Open)
Location
Hobart, NY (Pharma) - USA036
Additional Locations
Job Description
Performance of Functional Area & People Are Appropriate for Business Needs
Staff Aligned to Organizational Goals: Translates the corporate vision, values and goals into day-to-day activities and behaviors; guides and motivates others to take actions that support the vision, values and goals. Holds regular team meetings to ensure staff are kept in the loop. Performance Managed: Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly. Develops coaching partnerships with direct reports. Provides training and development plans. Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review. Change Leader: Acts as a champion for change. Encourages employees to question established work processes or assumptions; challenges employees to ask “why” until underlying cause is discovered; involves stakeholders in continuous improvement actions and alternatives. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities. Resources Allocated to Ensure Critical Priorities Are Met: Ensures money, technology, and staff are allocated to achieve optimal results. Culture of Continuous Learning & Improvement: Anticipates talents, skills and knowledge that will be needed in the organization; delegates tasks and responsibilities to others to grow skills while at the same time managing risk and establishing appropriate controls. Right People Selected & Onboarded: Ensures a clear and effective job description is developed prior to beginning recruitment efforts. Conducts thorough interviews that enable clear selection decisions; ensures onboarding processes drive rapid time to full productivity. Communication: Creates an atmosphere in which timely and high-quality information flows smoothly up and down, inside and outside of the organization; encourages open expression of ideas and opinions.
Safe, Effective Product Releases
Ensures the Quality Assurance groups successfully monitor the quality of all manufacturing and packaging activities including executing batch manufacturing and packaging records in accordance with specified timelines. Continually seeks ways to improve the Quality Culture of the site. Ensures the Quality Assurance groups successfully issue and control labels and labeling confirming that issuance is on time and accurate. Ensures the Quality Assurance groups successfully performs batch disposition activities to meet specified timelines. Ensures the batch disposition process is robust and continually seeks ways to improve the disposition process both in terms of effort expended, timeliness of disposition, and quality of work performed/quality of the disposition.
Effective, Efficient Quality System
Ensures the timely review of SOPs, work instructions, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements, where applicable. Establishes meaningful goals and metrics for groups in conjunction with the Site Quality Director, and manages the performance to those goals. Ensures the development, documentation and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance. Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented. Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done. Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
Investigations Reach Sound Conclusions and Effective CAPA's are Executed
Leads the team that provides Quality Assurance review and approval of deviations. Review includes the determination that deviation investigations are sound, meet current regulatory requirements and ensure product is safe and effective. Leads, manages and/or participates in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations. Works with individuals performing investigations to ensure the process is handled with the appropriate level of detail. Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products. Reviews and approves investigation reports to ensure it contains the appropriate level of detail; and appropriate CAPA's are identified.
Minimum Requirements
Education:
Bachelor's or Master's Degree in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies.
Experience:
Minimum of 10 years' experience in the pharmaceutical or similarly regulated industry, preferably in a Quality Assurance, Quality Control, Regulatory or Validation related position.
Minimum of 5 years in a Management or Supervisory position.
Knowledge of regulatory environment. Excellent oral and written communication skills. Excellent organizational skills. Proven decision-making ability. Proven personnel development ability. Good presentation skills. Experience in a DEA regulated environment is highly desirable.
Preferred Skills/Qualifications:
Continuous improvement mindset.Assertive assurance of quality throughout all operations within the facility. The ability to constructively work with colleagues when a Quality concern is in conflict with short-term business desires to successfully conclude the issue at hand to the best business advantage (both short- and long-term) without sacrificing the quality of work or the Quality Culture at the site.Extensive knowledge of FDA regulatory requirements applicable to pharmaceuticals. Applies GMP regulations and other international guidelines to all aspects of the position.Provides overall departmental feedback to Site Quality Director.Able to work with the goals and objectives of the Site Quality Director and translate them into actionable work for staff to meet those goals and objectives.Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.Actively takes the lead in ensuring GMP compliance for the company. Sets strategy in investigations and CAPAs, as necessary. Ensures follow up.Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).Participates and/or leads meetings, to provide input on timelines, potential compliance issues and other related Quality Assurance activities.Able to indirectly manage performance of people through direct reports.
Organizational Relationship/Scope:
Total Work Systems: Is dedicated to providing organization or enterprise-wide common systems for designing and measuring work processes; seeks to reduce variances in organization processes; delivers the highest quality products and services which meet the needs and requirements of internal and external customers; is committed to continuous improvement through empowerment and management by data; leverages technology to positively impact quality; is willing to re-engineer processes from scratch; is open to suggestions and experimentation; creates a learning environment leading to the most efficient and effective work processes.Directing Others: Is good at establishing clear directions; sets stretching objectives; distributes the workload appropriately; lays out work in a well-planned dialogue with others on work and results; brings out the best in people; is a clear communicator.Driving Execution: Sets and maintains high performance standards for self and others that support the organization's strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks.Managing & Measuring Work: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work.Building Organizational Talent: Anticipates talents, skills and knowledge that will be needed in the organization; seeks out opportunities to grow people's capabilities to match those needs; improves the results of others by identifying areas of performance strengths and development opportunities, by providing coaching, mentoring or development opportunities, and by providing clear, behaviorally specific feedback to team members and subordinates; creates a learning environment that ensures associates realize their highest potential, allowing the organization as a whole to meet future challenges.Managing Performance: Establishes clear expectations, provides timely, accurate feedback - both positive and negative - and takes appropriate follow-up actions, (for example, rewarding, publicizing successes, coaching and guiding); recognizes, rewards and promotes people based on their performance, achievement of results, and development of competencies; works with individuals to identify areas for development, understand need for improvement, and set specific development goals.
Senior Manager Quality Assurance
Requisition
JR000011845 Senior Manager Quality Assurance (Open)
Location
Hobart, NY (Pharma) - USA036
Additional Locations
Job Description
Performance of Functional Area & People Are Appropriate for Business Needs
Staff Aligned to Organizational Goals: Translates the corporate vision, values and goals into day-to-day activities and behaviors; guides and motivates others to take actions that support the vision, values and goals. Holds regular team meetings to ensure staff are kept in the loop. Performance Managed: Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly. Develops coaching partnerships with direct reports. Provides training and development plans. Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review. Change Leader: Acts as a champion for change. Encourages employees to question established work processes or assumptions; challenges employees to ask “why” until underlying cause is discovered; involves stakeholders in continuous improvement actions and alternatives. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities. Resources Allocated to Ensure Critical Priorities Are Met: Ensures money, technology, and staff are allocated to achieve optimal results. Culture of Continuous Learning & Improvement: Anticipates talents, skills and knowledge that will be needed in the organization; delegates tasks and responsibilities to others to grow skills while at the same time managing risk and establishing appropriate controls. Right People Selected & Onboarded: Ensures a clear and effective job description is developed prior to beginning recruitment efforts. Conducts thorough interviews that enable clear selection decisions; ensures onboarding processes drive rapid time to full productivity. Communication: Creates an atmosphere in which timely and high-quality information flows smoothly up and down, inside and outside of the organization; encourages open expression of ideas and opinions.
Safe, Effective Product Releases
Ensures the Quality Assurance groups successfully monitor the quality of all manufacturing and packaging activities including executing batch manufacturing and packaging records in accordance with specified timelines. Continually seeks ways to improve the Quality Culture of the site. Ensures the Quality Assurance groups successfully issue and control labels and labeling confirming that issuance is on time and accurate. Ensures the Quality Assurance groups successfully performs batch disposition activities to meet specified timelines. Ensures the batch disposition process is robust and continually seeks ways to improve the disposition process both in terms of effort expended, timeliness of disposition, and quality of work performed/quality of the disposition.
Effective, Efficient Quality System
Ensures the timely review of SOPs, work instructions, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements, where applicable. Establishes meaningful goals and metrics for groups in conjunction with the Site Quality Director, and manages the performance to those goals. Ensures the development, documentation and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance. Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented. Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done. Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
Investigations Reach Sound Conclusions and Effective CAPA's are Executed
Leads the team that provides Quality Assurance review and approval of deviations. Review includes the determination that deviation investigations are sound, meet current regulatory requirements and ensure product is safe and effective. Leads, manages and/or participates in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations. Works with individuals performing investigations to ensure the process is handled with the appropriate level of detail. Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products. Reviews and approves investigation reports to ensure it contains the appropriate level of detail; and appropriate CAPA's are identified.
Minimum Requirements
Education:
Bachelor's or Master's Degree in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies.
Experience:
Minimum of 10 years' experience in the pharmaceutical or similarly regulated industry, preferably in a Quality Assurance, Quality Control, Regulatory or Validation related position.
Minimum of 5 years in a Management or Supervisory position.
Knowledge of regulatory environment. Excellent oral and written communication skills. Excellent organizational skills. Proven decision-making ability. Proven personnel development ability. Good presentation skills. Experience in a DEA regulated environment is highly desirable.
Preferred Skills/Qualifications:
Continuous improvement mindset.Assertive assurance of quality throughout all operations within the facility. The ability to constructively work with colleagues when a Quality concern is in conflict with short-term business desires to successfully conclude the issue at hand to the best business advantage (both short- and long-term) without sacrificing the quality of work or the Quality Culture at the site.Extensive knowledge of FDA regulatory requirements applicable to pharmaceuticals. Applies GMP regulations and other international guidelines to all aspects of the position.Provides overall departmental feedback to Site Quality Director.Able to work with the goals and objectives of the Site Quality Director and translate them into actionable work for staff to meet those goals and objectives.Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.Actively takes the lead in ensuring GMP compliance for the company. Sets strategy in investigations and CAPAs, as necessary. Ensures follow up.Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).Participates and/or leads meetings, to provide input on timelines, potential compliance issues and other related Quality Assurance activities.Able to indirectly manage performance of people through direct reports.
Organizational Relationship/Scope:
Total Work Systems: Is dedicated to providing organization or enterprise-wide common systems for designing and measuring work processes; seeks to reduce variances in organization processes; delivers the highest quality products and services which meet the needs and requirements of internal and external customers; is committed to continuous improvement through empowerment and management by data; leverages technology to positively impact quality; is willing to re-engineer processes from scratch; is open to suggestions and experimentation; creates a learning environment leading to the most efficient and effective work processes.Directing Others: Is good at establishing clear directions; sets stretching objectives; distributes the workload appropriately; lays out work in a well-planned dialogue with others on work and results; brings out the best in people; is a clear communicator.Driving Execution: Sets and maintains high performance standards for self and others that support the organization's strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks.Managing & Measuring Work: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work.Building Organizational Talent: Anticipates talents, skills and knowledge that will be needed in the organization; seeks out opportunities to grow people's capabilities to match those needs; improves the results of others by identifying areas of performance strengths and development opportunities, by providing coaching, mentoring or development opportunities, and by providing clear, behaviorally specific feedback to team members and subordinates; creates a learning environment that ensures associates realize their highest potential, allowing the organization as a whole to meet future challenges.Managing Performance: Establishes clear expectations, provides timely, accurate feedback - both positive and negative - and takes appropriate follow-up actions, (for example, rewarding, publicizing successes, coaching and guiding); recognizes, rewards and promotes people based on their performance, achievement of results, and development of competencies; works with individuals to identify areas for development, understand need for improvement, and set specific development goals.
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Updated March 14, 2024