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17 days old

Quality - Manager, Compliance

Kelly Services
Manatí, PR 00674
**Quality - Manager, Compliance**


**PRINCIPAL OBJECTIVE OF POSITION** _This position is responsible for maintaining several elements within the Quality Systems frame work to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and_ _company_ _policies._


**MAJOR DUTIES AND RESPONSIBILITIES** :

Provide day to day support for the governance, management, and coordination of activities related to the Data Integrity Governance Program include implementing and maintaining Data Integrity compliance activities in alignment with relevant governmental regulations and guidelines.

Responsible for implementing company policies and procedures

Support and manage remediation efforts, utilizing QRM based principles to identify risk and establish appropriate prioritization.

Provide active support during regulatory agency and third-party inspections.

Acknowledge conducts and/or approve Regulatory Corrective Actions and Preventive Actions (CAPA),

Supports readiness of the facility for Regulatory Inspection. Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits.

Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.

Generates, reviews and implements departmental procedure and forms to assure compliance with current practices or GMPs trends.

Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.

Ensures that Quality and Compliance is implemented in laboratory and operational areas and maintains it according with regulatory agencies expectations.

Supports the Quality Risk Management program at the site participating in multidisciplinary teams.

Provides support to the Compliance and Auditing Data Integrity Senior Manager in the preparation of monthly Data Integrity Metrics and presentations.

Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule.

Provides compliance oversight and verifying compliance with company Policies, guidelines and regulations

Support Change Control Impact Assessments for the site.

Interaction with corporate support areas, other company sites and third parties.

Supports actively the MTI Site for Compliance with Data Integrity Regulatory expectations.

Provides guidance on Data Integrity compliance gaps identified at the site from the review and actively participates to determine potential remediation activities.

Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities.

Evaluates OPs, BRs, BOMs, WPPs, qualification and validation Protocols, according with government regulations and company Policies.


**Requirements:**


Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science. Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry. Fully Bilingual (Spanish/English) communication skills, both written and verbal are required. Strong knowledge of relevant GMP, FDA, EU regulations. Expert in the interpretation and application of regulations according with the intended use. Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses. Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and Trackwise.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-12 Expires: 2022-10-13

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Quality - Manager, Compliance

Kelly Services
Manatí, PR 00674

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