Talent.com
Senior Director, Operations
Senior Director, OperationsPCI Pharma Services • Bedford, NH, US
Senior Director, Operations

Senior Director, Operations

PCI Pharma Services • Bedford, NH, US
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Senior Director Of Manufacturing Operations

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective :

The Senior Director of Manufacturing Operations for our Bedford and Manchester sites is responsible for the manufacturing of aseptic and non-aseptic pharmaceuticals and medical devices in accordance with the most stringent quality, regulatory and safety standards. The Senior Director provides support to manufacturing managers, supervisors and associates and strives for excellence and continuous improvement to further enhance the sites' performance and client satisfaction. In conjunction with the Site General Manager, provides direction as well as develops and implements medium- and long-term plans.

Essential Duties and Responsibilities :

  • Acts as a technical expert and an escalation point for complex / high impact manufacturing issues / decisions
  • Oversees daily manufacturing of pharmaceuticals and medical devices at the Commerce and Sundial facilities, in compliance with all corporate and regulatory requirements
  • Responsible for maintaining cGMP compliance and accuracy of all documentation related to manufacturing.
  • Ensures that all departments operate in accordance with department SOPs which meet regulatory and cGMP standards
  • Instill a strong culture of Lean and Continuous Improvement through the use of the site maturity index.
  • Implements changes to procedures and documentation to ensure all regulatory requirements are being met
  • Responsible for management of production operations in accordance with all relevant health, Safety and Environmental legislation
  • Ensures safety policies and procedures are adhered to at all times. Recommends safety improvements, as necessary
  • Participates in regulatory inspections and client quality audits
  • Demonstrates substantial knowledge of industry best practices and trends of aseptic and / or medical device manufacturing practices
  • Identifies root causes of production problems and recommends improvements while working within cGMP regulatory requirement
  • Leads or participates on Project (client and internal) teams to represent the Operations organization
  • Accountable for identification of gaps, remediation and developing action plans for the implementation of systems to meet short- and long-term manufacturing goals
  • Makes key decisions and formulates policies that impact strategic objectives of the department
  • Provides leadership and guidance to direct reports and project team members to develop strong leaders and support the vision of the organization
  • Leads Operations personnel, including organizing and prioritizing group tasks
  • Writes performance reviews and oversees team development and communication by providing training, development opportunities and guidance to staff
  • Works with direct reports to ensure adequate staffing levels are maintained
  • Other tasks as assigned by management

Work Environment :

  • Works closely with internal operation teams
  • Interacts with all departmental staff and other departments at all levels
  • Must be comfortable presenting technical and complex issues clearly to all levels of management as well as client representatives
  • Management of 5 or more direct reports across multiple sites, some will have managerial responsibility
  • Qualifications :

  • 10+ years direct management experience with demonstrated leadership, team management and coaching skills. Demonstration of increasing responsibilities.
  • 10+ years of experience in cGMP pharmaceutical and / or medical device manufacturing, experience in both is preferred
  • Prior experience and knowledge of a CDMO or dealing with CDMOs strongly preferred
  • Extensive knowledge in aseptic fill / finish preferred
  • Previous experience with lyophilized products preferred
  • Working knowledge of FDA, ICH and EU pharmaceutical and / or medical device requirements, experience with both preferred
  • B.S. in Science, Chemistry or Engineering required
  • Excellent written and verbal, and interpersonal communication skills
  • Ability to work in a fast-paced environment and handle multiple tasks simultaneously
  • The ability to develop solutions to complex problems, which require a high degree of ingenuity, reactivity and innovativeness
  • Ability to lead others in a dynamic, fast paced work environment
  • Honesty, integrity, respect and courtesy with all colleagues
  • Creative with the ability to work with minimal supervision and balanced with independent thinking
  • Resilient through operational and organizational change
  • Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

    Equal Employment Opportunity (EEO) Statement : PCI Pharma Services is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose : Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

    serp_jobs.job_alerts.create_a_job

    Director Operation • Bedford, NH, US

    Job_description.internal_linking.related_jobs
    Director of Credentialing Operations

    Director of Credentialing Operations

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Manager of Credentialing and Compliance Operations to lead and scale the credentialing infrastructure for a nationwide healthcare staffing initiative.Key Responsibilities...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Manager of Customer Operations

    Senior Manager of Customer Operations

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Manager, Customer Operations to lead inbound virtual contact center teams.Key Responsibilities Build and maintain a high-performance culture by setting goals and...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director of Call Center Operations

    Director of Call Center Operations

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Call Center Operations responsible for overseeing the centralization of call center functions and enhancing service delivery. Key Responsibilities Lead the i...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Business Operations Senior Associate

    Business Operations Senior Associate

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Business Operations Senior Associate.Key Responsibilities Act as a strategic partner to leadership, driving high-impact business initiatives Lead and execute key cross...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director of Services

    Senior Director of Services

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director of Services.Key Responsibilities Define the vision and build a leading AI services organization, recruiting and mentoring a high-performing team Own th...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Business Operations

    Director of Business Operations

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Business Operations & Strategy (Marketplace Growth).Key Responsibilities Own the systems, strategy, and execution behind the quoting engine, automation infras...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Director of M&A Integration

    Senior Director of M&A Integration

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director of GDATS M&A Integration.Key Responsibilities Serve as the primary liaison to the GDATS Senior Leadership Team on all M&A tech integration initiatives ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Program Director

    Senior Program Director

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Program Director - Remote.Key Responsibilities Drive execution of operational plans for complex programs and initiatives related to assigned market segments Col...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Operations

    Director of Operations

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Operations to lead initiatives that improve outcomes for providers and patients in value-based care. Key Responsibilities Drive the operational strategy and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Clinical Operations

    Director of Clinical Operations

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Clinical Services Operations.Key Responsibilities Lead day-to-day operations ensuring compliance with contracts and regulations Develop and implement proce...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Care Operations

    Director of Care Operations

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Care Operations.Key Responsibilities Oversee day-to-day operations of the Enhanced Care Management program to meet delivery targets Grow and manage a multi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director of Capability

    Director of Capability

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Capability to lead cross-functional program implementation and drive operational performance. Key Responsibilities Provide strategic planning and direction t...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    GTM Operations Senior Manager

    GTM Operations Senior Manager

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a GTM Operations Sr Manager to optimize the operational foundation for its go-to-market team.Key Responsibilities Manage the process for setting, tracking, and reporting ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Engineering Director

    Senior Engineering Director

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    Director, Engineering to lead the global engineering vision and continuous improvement strategy for their Distribution and Logistics operations. Key Responsibilities Develop and execute the global...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Business Operations Associate

    Senior Business Operations Associate

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Associate, Business Operations.Key Responsibilities Partner with marketing, product, and business development teams to integrate customer performance insights in...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Director of SRE & Cloud Operations

    Senior Director of SRE & Cloud Operations

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director, Site Reliability Engineering & Cloud Operations.Key Responsibilities Lead the transition to containerized and cloud-native architectures using Azure se...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Operations Senior Manager

    Operations Senior Manager

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Manager, Operations.Key Responsibilities : Lead and mentor a global team for 24x7 support of production systems and services Establish and refine operational pro...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Client Operations

    Director of Client Operations

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Client Operations.Key Responsibilities Oversee day-to-day delivery of contracted operational services to clients Lead direct reports and manage client inqu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Director, Region Replenishment

    Senior Director, Region Replenishment

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director, Region Replenishment for the Northeast Region.Key Responsibilities Manage all Replenishment strategies and performance metrics for the assigned region ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Senior Manager of Contact Center Operations

    Senior Manager of Contact Center Operations

    VirtualVocations • Manchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Manager, Contact Center Operations.Key Responsibilities Build and sustain a high-performance culture by setting clear goals and enforcing accountability Work wi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new