Quality assurance manager/project manager job description

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

In this role you will support the department with both Project Management and Document Management skills
Activities will include, yet not be limited to:
Project Management (~50%)
Detailed Project Planning for designated projects (ranging from simple to complex) to include resource loaded schedules in the form of: GANTTs, Block Schedules, PPTs, determine critical paths, ‘pinch’ points, identifying enabling actions, Milestone Schedules and bringing forward forecasts of downtimes/ or lack of availability
Analysis of time and efforts for designated projects for understanding resources needed on time basis (FTE/week), deliverable basis (FTE/throughput), limitations of resources and periods of low utilization versus over utilization and required balancing
Tracking and reporting of milestones for team, manager, director, project members and senior leaders; which will be inclusive of plan progression, current activities, risks and analysis of impact for scenario planning (for example, “If we did this, then Milestone ABC will shift to XYZ” ); and, the reporting will take the form of succinct summaries with clear conclusions for deliverables (for example, a Comms Pack)
Communication to line management and identified stakeholders including Inputs/ Process/ Outputs, clear and concise articulation of Status, ASKs and Escalation for support and/or decision making
Proposing new strategies for innovating present WoW for a more efficient Future State – this may include leading/ facilitating brainstorming sessions, what if analyses, process mapping, etc.
Development of content for publication within the Client's systems for raising awareness, building culture, maintaining resilience and establishing a positive culture of performance and delivery
Day-to-Day Document/Data Migration (~40%)
Hand-on support as required including tracking, migrating and verifying data and documents between various repositories (internal and/or external)
Create and perform data mapping for understanding appropriate categorization of data per project/ the Client's requirements
Report on obstacles and inefficiencies with recommendations for improvement
Assignments may vary in size, duration and urgency, so flexibility and adapting to changing environments is likely to be required
Process Analytics and Trending
Identification of key analytic themes/ parameters and generation of any trending for understanding baseline framework, level of control and improvement
On-boarding training/On-going training on Client systems ~ 10 %
Additional Responsibilities
• Responsible for scheduling and planning work to meet priorities set by supervision. Sets specific daily and weekly priorities to meet timelines. Recommends procedures and policies to supervision.
#HP-CRGQA
LI-SW1


Education and Experience:
* Bachelor's degree or equivalent and relevant formal academic / vocational qualification
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
2 years).
Knowledge, Skills and Abilities:
* Compliance systems experience preferred
* Strong Project Management experience preferred
* Experience with Veeva Vault is strongly desired.
* Strong interpersonal skills required
* Strong verbal and written communication skills required
* Experience with controlled document computer systems required
* Keeps current on governmental regulatory requirements and the Client's standards related to biopharmaceutical clinical manufacture and control
* Experience with learning management systems preferred
* Experience with analysis and visualization tools (e.g. Power BI, Spotfire) preferred
* Biotechnology experienced preferred
* Knowledge of manufacture and/or testing of Biopharmaceutical Bulk Drug Substance (BDS)
* Ability to communicate, influence and negotiate at various levels
* Broad knowledge of the R&D Drug Development Process preferred
Working Environment:
/PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:/
* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
* Able to work upright and stationary for typical working hours.
* Ability to use and learn standard office equipment and technology with proficiency.
* Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
* May require travel. (Recruiter will provide more details.)
* As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.


Job: **Training and Development*


Organization: **US BU*


Title: Project Manager - QA Veeva Vault


Location: PA-King of Prussia-FSP King of Prussia PA

This position stays abreast of the requirements, regulations and developments related to quality assurance (QA) and food protection as it applies to the food distribution industry. This position is responsible for creating and maintaining a product protection culture that ensures all operational processes meets QA requirements. This position

is also responsible for understanding and communicating all aspects of safety and ensuring all operational activities are performed in a safe manner.
ESSENTIAL JOB FUNCTIONS:

Act as a content expert for quality assurance. Must understand all customer QA requirements and relevant government entities.

Maintain procedures and training manuals required to ensure compliance with QA requirements.

Perform internal mock audits and serve as primary point of contact for all QA audits.

Facilitate all federal, state and local inspections of the facility including documentation of the site visit.

Conduct internal inspections to ensure all QA records and logs are maintained properly (i.e. yard temperature pre-cool logs, thermometer calibration logs, ambient temperature logs, master sanitation

schedule, rapid resupply binder, disaster recovery binder and the HAACP/QCP binder).

Ensure all operations are in compliance with government regulations and requirements (i.e. DOT, OSHA, local and state agencies, etc.).

Partner with the department heads to provide QA and safety guidance and safety-related training, including but not limited to Pure Safety, MHE, lifting, defensive driving, PTDC, sanitation, CPR/First Aid and new hire

training.

Lead all safety-related programs including monthly safety committee meetings, safety 5-Os, required review and communication of the Management Safety Standards, teammate meetings safety topic reviews, safety blitz, updating the safety awareness boards, post-accident and injury preventability rulings and retraining.

Other duties as assigned.

MINIMUM REQUIREMENTS:

Bachelor's degree in a related field.

5-7 years' experience in warehousing, distribution, QA and/or safety.

Understand computer software related to record keeping and communication. Preferred experience with Microsoft Office Applications.

Experience in managing, training and directing large work groups.

Ability to write reports, business correspondence, procedure manuals, inter-company and outside correspondence.

Experience in planning and or analytical reporting.

Document, analyze and interpret general business periodicals, professional journals and technical procedures.

Manage multiple priorities.

Understand financial statements and cost implications. Possess ability to identify issues and present effective solutions.

Effectively present information and respond to questions from groups of managers, vendors and teammates.

Strong communication skills and work within the framework of a team.

WORKING CONDITIONS:

Must be able to continuously walk, stand, and climb over the period of their shift.

Work in all areas of a distribution center and may require work in hot and cold temperature extremes and exposure to dust, dirt, fumes, noise, potentially harmful chemicals and solvents.

Work in close proximity to other teammates.

'48351

**THE OPPORTUNITY**

The Food Safety and Quality Project Manager supports the FSQA team by managing all new menu development project work for the department and conceiving, outlining, and developing internal projects as needed. This manager creates project goals and success markers while determining how progress will be measured and tracked. They ensure that the food safety-related tasks of each project are completed on or before the cross-functional due dates and motivates team members and stakeholders to hit their goals. The Project Manager acts as a liaison between the FSQA team and stakeholder management (Brand Marketing, Culinary, Supply Chain, and Operations) and gives updates to the cross-functional teams as needed. They also prepare and present progress reports on relevant metrics associated with each project to be presented across the project teams, including VP-level and higher, within the organization. With the primary focus and oversight of a world class restaurant food safety and quality assurance program, this individual ensures the Food Safety and Quality team is put in the best position to execute and implement projects in a way that ensures Food Safety is built into all new menu items, changes to existing menu items, and any project that improves the Food Safety and Quality of our food. This manager is expected to utilize Chipotle Mexican Grill's internal programs and processes for project management, but is also expected to bring new tools, programs, or processes to the table to ensure the enterprise is utilizing the best tools available to meet project goals.

**WHAT YOU'LL DO**

In addition to following Chipotle's policies and procedures, principal accountabilities include, but are not limited to:

+ Work directly with cross functional project teams and stakeholders to communicate FSQA requirements, timing, scope, and metrics required for the successful completion of projects in such a way that ensures Food Safety and Quality are built in each project.

+ Delegate project tasks to FSQA managers based on the members' category assignments, experiences levels, strengths, skill sets, and bandwidth.

+ Track performance, analyze metrics, and develop effective reporting mechanisms to ensure successful completion of short- and long-term initiatives.

+ Meet budgetary and time-bound objectives and make adjustments or escalate issues related to project constraints when necessary.

+ Develop comprehensive project plans and scorecards to be shared with the project team, stakeholders, and executive leadership.

+ Monitor industry-best practices related to project management and implement these practices where applicable/appropriate.

+ Assisting Chipotle QA team with additional quality assurance and food safety responsibilities as needed (backing up Food Safety Managers and Analysts with Food Safety and Quality site audits when required, quality report monitoring, etc.).

**WHAT YOU'LL BRING TO THE TABLE**

+ B.A./B.S. in Food Science, Agricultural Sciences, Quality Assurance, or related field. (chemistry, biology, biochemistry, or microbiology)

+ Masters Degree preferred

+ 5-8 years of experience in Food Safety and Quality Assurance with Project Management experience.

+ Able to execute and effectively communicate FSQA requirements and timelines to cross-functional stakeholders (Culinary, Brand Marketing, Operations, & Supply Chain) in order to manage expectations and allow other teams to execute according to FSQA timelines and requirements.

+ Enjoys working within quality management systems.

+ Must be proficient in Microsoft Office as well as project tracking/reporting software (primarily Smartsheets).

+ Be a critical thinker with strong analytical and technical skills with the capability to collect and clearly analyze data and report results.

+ Possess extraordinary organization skills and ability to prioritize projects.

+ Thrive in a fast-moving, high stakes environment.

+ Able to occasionally travel by air.

+ Able to drive own vehicle to Orange County area restaurants, distribution centers, and suppliers.

**WHO WE ARE**

Chipotle Mexican Grill, Inc. (NYSE: CMG) is cultivating a better world by serving responsibly sourced, classically-cooked, real food with wholesome ingredients without artificial colors, flavors or preservatives. Chipotle had over 3,000 restaurants as of June 30, 2022, in the United States, Canada, the United Kingdom, France and Germany and is the only restaurant company of its size that owns and operates all its restaurants. Chipotle is ranked on the Fortune 500 and is recognized on the 2022 list for Fortune's Most Admired Companies. With over 100,000 employees passionate about providing a great guest experience, Chipotle is a longtime leader and innovator in the food industry. Chipotle is committed to making its food more accessible to everyone while continuing to be a brand with a demonstrated purpose as it leads the way in digital, technology and sustainable business practices. For more information or to place an order online, visit WWW.CHIPOTLE.COM.

**CULTIVATING A BETTER WORLD**

Food served fast does not have to be a typical fast-food experience. Chipotle has always done things differently, both in and out of our restaurants. We are changing the face of fast food, starting conversations, and directly supporting efforts to shift the future of farming and food. We hope you will join us as we continue to learn, evolve, and shape what comes next on our mission to make better food accessible to everyone.

Primary Location: California - Newport Beach - 9998 - 610 Newport Office-(09998)

Work Location:

9998 - 610 Newport Office-(09998)

610 Newport Center Drive

Newport Beach 92660