Contact Center Quality Analyst, Sr. jobs in Worcester, MA

Job Summary:

The Sr. Director, Quality Operations for the Pharma Storage and Services business unit is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Sr Director, Quality provides leadership to the site Quality team who perform quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with site management to ensure department goals and objectives are met. The Sr Director, Quality interacts with clients and regulatory agencies regarding quality issues, audits, and inspections. This role will be responsible for Quality oversight at 3 Pharma Storage and Services (PSS) locations: MA, NV, and NC.

On-Site Expectations:

• 100% on-site position.

Responsibilities:

• Ensures GMP compliance to regulatory requirements and Company procedures. Specifically, 21 CFR parts 210 and 211; Eudralex Volume 4, as applicable to PSS scope of work.
• Collaborates with corporate quality functions to ensure site compliance with the company’s Quality Management Systems (QMS).
• Collaborates with site Operations and Technical leadership to ensure timely closure of deviations, non-conformance investigations, corrective actions, and other Quality documents.
• Supports site leadership to ensure thorough root-cause analysis for investigations.
• Provides oversight to ensure appropriateness and timely implementation of corrective and preventive actions; focus to eliminate repeat observations.
• Guides, instructs, and coaches members of management in quality and compliance issues.
• Provides direct support and leadership during site regulatory inspections to ensure minimal observations.
• Engages in client audits and client interactions.
• Assists in driving on-time site responses to regulatory and client audit reports and provides direct oversight on commitments and content.
• Develops and implements systems to aid in efficiency and compliance improvements for the site.
• Develops short and long-range goals and objectives for the site quality function.
• In collaboration with Compliance leadership, develops, supports, and maintains internal auditing program.
• Ensures controlled documentation is generated, revised, approved, and maintained per corporate and regulatory agency procedures.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree and a minimum of 15 years of related experience required.
• A minimum of 8 years of supervisory experience is required.
• Prior pharmaceutical experience in GMP storage, sampling and material management is required; prior CDMO experience preferred.
• Prior experience with ERP system implementation oversight is also desired.

Knowledge, Skills, and Abilities:

• Strong technical skills for area managing.
• Strong business acumen.
• Strong understanding of company SOPs, and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Strong knowledge of cGMP requirements.
• Strong experience with client audits.
• Strong knowledge of FDA, EU and ICH requirements and implementation for GMP in the pharmaceutical industry.
• Experience with regulatory agency inspections of GXP facilities.
• Experience working with CDMOs.
• Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites.
• Excellent analytical and problem-solving skills, with the ability to think strategically.
• Strong attention to detail, as well as time and resource management.
• Good presentation skills.
• Promote a safe environment for work.
• Comply with the general policy of the company.
• High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
• Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
• Communicate well orally both for internal customers and team members as well as external customers
• Ability to write reports and business correspondences.
• Ability to listen and respond well to external customers, partners, and colleagues at all levels.
• Highly goal and result oriented.
• Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
• Can work independently with a high degree of self-motivation.
• Knows how to obtain support from different collaborations.
• Tackles problems with enthusiasm and curiosity.
• Treats colleagues at all levels with respect.
• Very effective listening skills with the ability to listen attentively and process information correctly.

Travel Expectations:

• Minimally 30% travel.