Job Summary:

Reporting to the Sr. Director, Global Quality, the Director, Quality & Compliance is responsible for the Quality function at the AVEVA Tamarac manufacturing facility. The Director, Quality & Compliance has oversight over all GxP activities and functions including Quality Manufacturing & Release, Quality System, Quality Control ,Microbiology, Compliance and Risk Management. Quality organization is an independent function and is responsible for making all final GxP decisions within their area of responsibility. The quality decisions cannot be overruled. The Director, Quality & Compliance is appointed Management Representative for Aveva with authority and responsibility for ensuring that quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820. The incumbent is responsible for reporting on the performance of the quality system to management with executive responsibility for review. The Director, Quality & Compliance, directs quality compliance and risk based evaluations and provides in-depth technical support for sterile and non-sterile manufacturing processes, technology concepts and process development and QA validation activities to ensure that these departments support the divisional goals and strategic plans of Aveva. The Director, Quality & Compliance has complete responsibility for all aspects of quality assurance and quality control at the site, making sure that the products released are fit for their intended use, comply with the requirements of regulatory filings, and do not place patients at risk due to inadequate safety, quality or efficacy. The Director, Quality & Compliance monitors Government, Customer and Industry Quality system requirements to assure procedures are adequate and in compliance; oversees Regulatory Agency certification and periodic audits; is responsible for formulating, documenting, implementing and assuring compliance to Global Quality policies, plans and standards; and represents the site QA organization, among other duties.

Job Responsibilities

Accountable for overall Quality and regulatory compliance at the site, resulting in a reliable product supply to customers through the Aveva Supply Chain.

Provides input or approval for facility, equipment and process design specifications, qualifications, validations and control programs.

Proposes solutions and pushes the organization to resolve difficult problems and address knowledge and/or resource gaps.

As the highest point of Quality issues escalation for the site, responsible for overseeing the assignment and completion of investigations, corrective/preventive actions and CAPAs; and escalating risks to Corporate Quality with a plan of action, mitigation and execution timelines.

Play an active leadership role in maintaining a sustainable Quality culture at the site, and contribute to the development of quality policy for Aveva as a whole.

Effectively manage site Quality Systems, ensuring compliance with cGMPs, Global Policies and SOPs.

Coordinate implementation and monitoring of post-approval changes with Product Development, Technical Operations, and Regulatory Affairs.

Perform site wide GMP documentation gap analysis against Global Quality Policies & SOPs, and revise documents as needed.

Ensure that all automated GMP facilities, equipment and business solutions are 21 CFRPart 11 compliant via the appropriate procedures and international guidelines.

Represent Aveva to Regulatory Agencies and Industry Groups in order to develop and influence industry standards with respect to overall operation processes and procedures.

Lead timely preparations for Health Authority Inspections (FDA, Health Canada, etc.) and act as the primary spokesperson for the site during inspections.

Manage responsibilities in regard to Regulatory Agency certification and periodic audits at the site for a fully compliant outcome.

Remain current with industry trends and Health Authority expectations.

Influence standards accordingly, and incorporate and translate standards into business processes to ensure continuous improvement.

Manage the site Internal Audit Program.

Sponsor best practice sharing, harmonization and standardization, LEAN deployment and a continuous improvement mindset.

As a member of the site leadership team, define and manage targets and objectives for the site and Quality Department that are aligned with company Global QA strategy and objectives.

Manage Site QA QPIs/metrics, monthly reporting and corrective actions at the site. Analyze internal and external Quality data and initiate effective preventive and corrective actions to reduce and eliminate adverse trends.

Manage an effective complaint management process at all levels and across the organization by monitoring complaints follow-up for effective resolution

Actively participate in Quality council meetings and translate overall strategy into programs for implementation. Participate in global forums to set Quality Assurance policy and strategy.

Support all Aveva Global Quality Organization Projects at the site level.

Ensure engagement of various site departments and functions towards Global Quality targets and initiatives.

Implement a business planning process and champion initiatives that will identify future business needs and opportunities through regular communication with internal customers and resource departments

As leader of the site Quality organization, provide an environment that enables and encourages all employees to contribute to their full potential.

Champion the implementation of Global Quality strategic initiatives at the site level

Responsible for people and organization development, and playing a key role in hiring, assessment, development, talent management and leadership development.

Analyze training gaps and maintain GMP training at the site to ensure compliance with GxP, regulatory standards and Company Global GMP Training programs.

Support Aveva programs which align employee behaviors with Avevas Corporate Values.

Actively demonstrate quality values of pride, accountability, integrity and diligence.

Develop, with the Vice President of Operations, departmental expense, capital budgets and headcount projections.

Track and manage expenditures and headcount to budget over the fiscal year.

Assist the Vice President of Operations in following up on the assigned tasks given; performs the essential duties of a Quality management.

Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, which includes, but is not limited to:

o Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our global job description processes

o Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Global Training and Employee Qualification Enterprise Policy

o Effectively managing performance for direct reports according to the Global Performance Management Program,

o Attracting and retaining talent based on our talent management framework

o Scheduling regular one-on-one meetings, probationary performance reviews and midyear performance discussions

o Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and

o Responsible to ensure compliance of team members (direct reports) with the Global Business Ethics and Compliance Program, Global Quality procedures, Safety and Environment policies, and HR policies. o Works as a member of a team to achieve all outcomes;

o Leads with a global mindset that respects all cultural dimensions

o Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements

o Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and

o All other duties as assigned.

Education

Masters Degree in Chemistry, Pharmacy, or related scientific field from an accredited college or university.

Knowledge, Skills and Abilities

Masters Degree in Chemistry, Pharmacy, or related scientific field from an accredited college or university

o Must have working background in a manufacturing facility, and knowledge of regulations and practices pertaining to pharmaceutical/biological products

o Experiential knowledge and application of Food and Drug Administration (FDA), Health Canada and other international regulations

o Interpreting and applying federal, state and local policies and procedures.

o Ability to interact with regulatory agencies

o Demonstrate advanced ability to evaluate and apply compliance requirements/guidelines to complex situations

o Excellent leadership capability with demonstrated track record of leading the quality organization for AVEVA/Difgen pharmaceutical products

o Creating, planning, and implementing goals, objectives, and practices for effective and efficient and cost effective management of allocated resources.

o Preparing, presenting and administering complex budgets and financial reports

o Excellent communication, facilitation, presentation and technical writing skills

o Advanced skills in solving complex problems, with the ability to bring issues to resolution

o Advanced skills in handling multiple responsibilities, tasks and projects simultaneously, including ability to shift priorities

o Directing, coordinating, designating and reviewing the work of assigned department personnel.

o Demonstrate advanced leadership skills, with a focus on strategy and continuous improvement

o Establishing and maintaining cooperative working relationships with others.

o Advanced skills in leading, motivating, influencing, and negotiating with staff

Experience

o 10 years of experience in Pharmaceutical Quality Operations

o 5 years of experience in a management/leadership position